cyrilzakka/clinical-trials huggingface dataset:
Safety, Pharmacokinetics and Pharmacodynamics Study of HL-032 in Healthy Male Volunteers

The purpose of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics of HL-032 after oral administration in healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects
* Age(yr)between 19 and 50
* Signed written informed consent

Exclusion Criteria:

* Known hypersensitivity to Octreotide or hGH(human growth hormone)
* History of Cardiovascular, Respiratory, Renal/Genitourinary, Gastrointestinal, Neurological/Psychic, cancer
* Alcoholic, smokers or drug abusers
* Other conditions which in the opinion of the investigator preclude enrollment into the study
A Study Based on Japanese Medical Records That Looks at Bleeding Events in People With Atrial Fibrillation and Coronary Artery Disease Who Start Taking Either Dabigatran, Rivaroxaban, or Warfarin

The study aims to evaluate the safety and effectiveness comparisons between warfarin, dabigatran, and rivaroxaban in routine clinical practice among Japanese non-valvular atrial fibrillation (NVAF) patients with concomitant coronary artery disease (CAD).


Eligibility Criteria:
Inclusion Criteria:

-≥18 years of age

* Has one year of look-back period prior to the index date (defined as the first date of prescription for dabigatran, rivaroxaban, or warfarin during the study period)
* New users of warfarin, dabigatran, and rivaroxaban, defined as patients without historic use of any oral anticoagulants during the look-back period
* Has at least 1 diagnosis of NVAF during the look-back period prior to or on the index date
* Has at least 1 diagnosis of CAD during the look-back period prior to or on the index date

Exclusion Criteria:

* Diagnosed with end-stage renal disease, or undergo hemodialysis, or experience pregnancy during the study period
* Initiate warfarin, dabigatran, rivaroxaban due to valvular Atrial Fibrillation (AF), AF associated with mechanical valve malfunction or mechanical complication of heart valve prosthesis, or rheumatic AF
* Underwent joint replacement procedures or diagnosed with venous thromboembolism during the look-back period prior to or on the index date
* Prescribed with more than 1 oral anticoagulation (OAC) on the index date
* Prescribed with more than 2 anti-platelet drugs per prescription (triple or quadruple anti-platelet use), or prescribed with any anti-platelet injection
* Patients with missing or ambiguous age or sex information
Development of Clinical Assessment Technique Using Multi-radiotracer PET/MR in Prostate Cancer

To development of clinical assessment technique using multi-radiotracer positron emission tomography/magnetic resonance (PET/MR) in prostate cancer

* to establish the optimal imaging technique of PET/MR using multiple radioactive tracers for prostate cancer
* to establish the imaging biomarker using PET/MR for clinical assessment of prostate cancer and early detection of recurrent prostate cancer

To establish the optimal imaging technique of PET/MR using multiple radioactive tracers for prostate cancer

* Recruiting 30 patients with prostate cancer ahead to radical prostatectomy
* PET/MR using 18F-choline with dedicated prostate MRI in all patients
* PET/MR using 18fluoride(F)-fluorodeoxyglucose(FDG)in all patients after 2-7 days
* PET/CT using 18F-FDG in all patient immediate after 18F-FDG PET/MR
* outcome assessment: comparison of scan time, image quality, tumor detection rate, standardized uptake values of lesions
* establishing optimal imaging technique for prostate PET/MR

To establish the imaging biomarker using PET/MR for clinical assessment of prostate cancer

* comparison of findings on PET/MR, MRI and PET/CT with pathological mapping after radical prostatectomy
* outcome assessment: accuracy of PET/MR for localization and staging of prostate cancer compared with MRI only and PET/CT only

To establish the imaging biomarker using PET/MR for early detection of recurrent prostate cancer

* Recruiting 15 patients with recurrent prostate cancer treated by surgery, hormone, or radiation therapy
* Recruiting 15 patients with treated prostate cancer without recurrence
* PET/MR using 18F-choline with dedicated prostate MRI in all patients
* PET/MR using 18F-FDG in all patients after 2-7 days
* PET/CT using 18F-FDG in all patient immediate after 18F-FDG PET/MR
* comparison of findings on PET/MR, MRI, and PET/CT with clinical data in two patient groups with or without recurrent prostate cancer
* outcome assessment: accuracy of PET/MR for early detection and localization of recurrent prostate cancer compared with MRI only and PET/CT only

Eligibility Criteria:
Inclusion Criteria:

* patient with prostate cancer before treatment
* patient with prostate cancer treated
* patient with prostate cancer recurrent

Exclusion Criteria:

* patient with contraindication for MRI
* Patient with severe renal impairment
Stroke Survival in Municipalities: Impact of Geographic Proximity to First- and Second-degree Relatives

Our key objective will be to investigate if geographic proximity to first- and second-degree relatives has an influence on post-acute stroke survival and use of health and social services. We will also model and map spatial variation in stroke and cardiovascular disease (CVD) incidence and mortality and see if some of the variation is due to spatial clustering of familial risk. The study will use innovative approaches to large-scale registry and survey data and statistical analysis on the full Norwegian population. We will integrate multigenerational and geographical information. This will enable us to assess key determinants on stroke survival and use of health and social care at municipality level.


Eligibility Criteria:
Inclusion Criteria:

* Norwegian citizens aged 45 and above 1.1.1994 - 31.12. 2009 and had stroke events
* Those who attend a cardiovascular health survey who later developed stroke.
* All Norwegians born in the period 1 January 1940 to 31 December 1959 who survived to 1991
* Norwegian citizens aged 45 and above 1.1.2016 and had stroke events

Exclusion Criteria:

-
A Study to Evaluate Safety and Tolerability of a Therapeutic Vaccine, ASP0113, in Subjects Undergoing Allogeneic Hematopoietic Cell Transplant

This study is to evaluate safety and tolerability of a therapeutic vaccine, ASP0113, in subjects undergoing allogeneic HCT. The occurrence of CMV viremia and immunogenicity are also assessed.


Eligibility Criteria:
Inclusion Criteria:

* Subject is planned to undergo either of the following:

  * Sibling Donor Transplant - 7/8 Human Leukocyte Antigen (HLA)-A, -B, -C, -DRß1 match utilizing high resolution typing or 8/8 (HLA)-A, -B, -C, -DRß1 match utilizing low or high resolution typing.
  * Unrelated Donor Transplant - 7/8 or 8/8 HLA-A, -B, -C, -DRß1 match utilizing high resolution typing.
* Subject has one of the following underlying diseases: Acute myeloid leukemia (AML) /Acute lymphoblastic leukemia (ALL) / Acute undifferentiated leukemia (AUL) /Acute biphenotypic leukemia / Chronic myelogenous leukemia (CML) / Chronic lymphocytic leukemia (CLL) / myelodysplastic syndrome(s) (MDS)
* Subject is scheduled to receive an allogeneic peripheral blood stem cell (PBSC) or bone marrow transplant (BMT) for the treatment of hematologic disorders

Exclusion Criteria:

* Subject has active CMV disease or infection or has received treatment for active CMV disease or infection within 90 days prior to transplant
* Subject has planned CMV prophylactic therapy with antiviral drugs or CMV-specific immunoglobulins
* Subject has a modified hematopoietic cell transplant comorbidity index (HCT-CI) score \> 3
* Subject is known to be positive for human immunodeficiency virus (HIV), hepatitis B surface antigen or hepatitis C ribonucleic acid (RNA)
* Subject has received any of the following substances or treatments:

  * T-cell depletion of donor cell product.
  * Alemtuzumab within 60 days prior to transplant, including conditioning regimen. Subjects for whom treatment with alemtuzumab is planned at any time from 60 days prior to through one year post-transplant should not be enrolled in the trial.
  * Administration of a CMV vaccine, including any prior exposure to ASP0113.
* Subject has received an allogeneic stem cell transplant within one year prior to transplant
* Subject has a current malignancy in addition to the malignancy being treated for the study or the subject has a history of any other malignancy
* Subject has an unstable medical or psychiatric condition, including a history of illicit drug(s) or alcohol abuse that the Investigator believes will interfere with protocol requirements.
The Effects of Glimepiride in Patients With Type 2 Diabetes and Chronic Heart Failure

Thirty years ago, Dzau and Braunwald introduced the concept of a continuum of cardiovascular diseases and defined them as a series of events caused by numerous related and unrelated risk factors, thus developing to end-stage heart disease through many pathophysiological pathways and processes. Owing to treatment concept changes and the urgency of investigating T2D combined with CHF, SUs are being re-evaluated, of which glimepiride is undoubtedly the most promising.

Since the first sulfonylurea (SU; tolbutamide) was commercially launched in Germany in 1956, SUs, as the oldest oral hypoglycemic drugs, have been developed for three generations and are commonly used for patients with T2D. In 2008, the US Food and Drug Administration and European Drug Administration required cardiovascular safety certification for all hypoglycemic drugs, resulting in increased related clinical trials. Currently, data on the relationship between SUs and cardiovascular outcomes are limited, and the cardiovascular effects remain controversial in observational studies. Third-generation SUs, such as glimepiride, are widely used for treating T2D because of their definite hypoglycemic efficacy, relatively low risk of hypoglycemia, convenient daily use, and low price. Glimepiride has good cardiovascular safety according to randomized controlled trials (RCTs). The proportion of SUs used in patients with heart failure is as high as 60.4%. Although some studies have shown that SUs are neutral in terms of hospitalization rates and adverse cardiovascular events in patients with CHF, no standard RCT of glimepiride has been conducted to study its effect on the prognosis of patients with T2D and confirmed CHF. Glimepiride inhibits soluble epoxide hydrolase (sEH), thus reducing epoxyeicosatrienoic acid (EET) degradation . Increased EET production exerts protective effects on the heart, indicating the potential cardiovascular effect of glimepiride.

This retrospective cohort study aimed to evaluate the effects of glimepiride on the clinical outcomes of patients with T2D and CHF and provide theoretical evidence for the clinical application of glimepiride in these patients.

Eligibility Criteria:
Inclusion Criteria:

* Chronic heart failure (\>6 months duration, according to 2021 ESC Guidelines for the Diagnosis and Treatment of Acute and Chronic Heart Failure)
* Reduced ejection fraction defined as LVEF \< 50%
* N-terminal pro-brain natriuretic peptide (NT-proBNP) level: \>125 pg/mL
* NYHA-class II/III/IV with stable symptoms for at least the past 3 months
* Type 2 diabetes (according to the Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes-2022)

Exclusion Criteria:

* Those who did not meet the diagnostic criteria
* Lacked echocardiographic and NT-proBNP data
* Used sulfonylureas other than glimepiride were excluded
Effect of Enteral Nutrition Enriched in Protein and Based on Indirect Calorimetry Measurement in Chronically Critically Ill Patients

This is a single-center, prospective, randomized, comparative, double-blind controlled clinical study intended to establish 1) the optimal method of determining calorie requirements and 2) the optimal amount of protein supply in chronically ventilated patients.

The study will be performed in a chronic ventilation department.

Enrolled patients will be randomly allocated to receive calories as dictated by:

The Harriss-Benedict formula (Group 1) or Indirect Calorimetry (Group 2)

After one week of admission to the hospital department and study enrollment we will review the first results of the study.

After seven days of hospitalization and study enrollment patients who have not been weaned from the ventilator, will be divided into three groups.

1. Patients in the first group will receive caloric support calculated by the HARRISS BENEDICT equation and protein dose of 1.1 to 1.5 grams per kilogram weight.
2. Patients in the second group will receive caloric support as measured by indirect calorimetry and will receive protein at 1.1 grams per kilogram weight.
3. Patients in the third group will receive caloric support as measured by indirect calorimetry and will receive protein at a dose of 1.5 grams per kilogram weight.

Outcome of treatment results will be performed after one ,four and eight weeks:

1. Length of hospitalization
2. Weaning from Mechanical Ventilation
3. Development and progression of pressure ulcers
4. Infectious diseases incidence
5. Amount of insulin needed for glucose control
6. Length of mechanical ventilation
7. Readmission to Intensive Care Unit
8. Mortality rate

Eligibility Criteria:
Inclusion Criteria:

* Chronically Mechanical Ventilated Patients (more than 21 days of Mechanical Ventilation) by tracheostomy,
* Between ages 65-90

Exclusion Criteria:

* Patient over age 90 and younger the age of 65
* PH level less than 7.3 due to metabolic causes.
* A patient with blood albumin level less than 2.2 g / dl
Pharmacokinetics Of CP-690,550 In Patients With Impaired Renal Function

A study to evaluate the pharmacokinetics of CP-690,550 in subjects with mild, moderate or severe renal impairment, who do not require hemodialysis, compared to healthy controls.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with normal renal function: Subjects must be healthy with estimated creatinine clearance \>80 mL/min
* Subjects with renal impairment: Subjects should be in good general health commensurate with the population with chronic kidney disease

Exclusion Criteria:

* Kidney transplant patients
* Subjects with any condition possibly affecting drug absorption
* Subjects with malignancies with the exception of adequately treated basal cell carcinoma of the skin
Sex Differences in the Dilatory Response of Compound 21

When blood pressure changes, Angiotensin II is produced and released into the bloodstream. This substance can make blood vessels smaller (i.e., vasoconstriction) by acting through Angiotensin II type I receptors (AT1R) to increase blood pressure. Or it can increase the diameter of vessels (i.e., vasodilation) through Angiotensin II type II receptors (AT2R) to decrease blood pressure. These two receptors normally work in balance to maintain blood pressure. However, excess Angiotensin II released in the bloodstream may reduce the sensitivity of AT2Rs, leading to excessive activation of AT1Rs. This results in increased constriction which plays a major role in diseases such as high blood pressure, hardening of the arteries, and heart failure. In the body, Angiotensin II production is reduced in the presence of estrogen, as seen in pre-menopausal women. Pre-menopausal women have a greater protection against cardiovascular diseases compared to age-matched males, likely due to the protective effects of estrogen. However, the extent that estrogen may impact the sensitivity of Angiotensin II receptors in pre-menopausal is unknown.

In this study, the investigators use the blood vessels in the skin as a representative vascular bed for examining mechanisms of microvascular dysfunction in humans. Using a minimally invasive technique (intradermal microdialysis for the local delivery of pharmaceutical agents), the blood vessels in a dime-sized area of the skin are studied in healthy young women and men. As a compliment to these measurements, blood is drawn from the subjects and circulating factors that may contribute to cardiovascular health are measured.


Eligibility Criteria:
Inclusion Criteria:

* Young women or men,
* 18-35 years old,
* Body mass index between 18 and 30 kg/m2,
* Systolic blood pressure \<140,
* Diastolic blood pressure \<90 mmHg.

Exclusion Criteria:

* Skin allergies, skin disorders, or skin diseases such as Raynaud's phenomenon or other history of cold intolerance,
* History of metabolic or cardiovascular disease,
* Taking medications that could alter vascular function, including antidepressants, anxiety medications, or cholesterol or blood pressure lowering drugs,
* Women with oligo- or amenorrhea,
* Women that are pregnant or nursing
* current tobacco use,
* Allergy to materials used during the experiment (e.g. latex).
Dose Ranging Study - Macroflux Parathyroid Hormone (PTH) in Postmenopausal Women With Osteoporosis

A Multi-center study to determine effects of various doses of Macroflux Parathryroid Hormone (PTH) in women with osteoporosis


Eligibility Criteria:
Inclusion Criteria:

* Healthy postmenopausal women age 50 years or older
* At least three lumbar vertebrae (L1-L4) must be evaluable by dual energy x-ray absorptiometry (DXA) for bone mineral densitometry that is, without fracture or significant degenerative disease, as determined by the central imaging facility
* Have osteoporosis defined as: Either a T-score of ≤ -2.5 at the lumbar spine, femoral neck, or total hip, AND a T-score of at least \< -1.0 at the lumbar spine; or A T-score of ≤ -2.0 at the lumbar spine, femoral neck, or total hip, AND at least one vertebral fracture;

Exclusion Criteria:

* Active hepatitis;
* Active pancreatitis;
* Unstable cardiac disease;
* Unstable pulmonary disease;
* Celiac disease;
* Hyper- or hypo-parathyroidism;
* Hyperthyroidism;
* Cushing's disease;
* Osteomalacia;
* Paget's disease;
* Osteogenesis imperfecta;
* Known blood disorders;
* History of kidney stones;
* Impaired renal function;
* Autoimmune diseases;
* Bone metastases or a history of skeletal malignancies;
* Cancer history that includes any cancer within the previous 5 years, with the exception of squamous or basal cell carcinoma of the skin in which the lesions were fully resected with clear margins described in a written report by a pathologist, and the patient has had no recurrence of lesions for at least 1 year from the time of original resection;
* Any condition or disease that may interfere with the ability to have or the evaluation of a DXA scan, for example, severe osteoarthritis of the spine, spinal fusion, pedicle screws, history of vertebroplasty, or degenerative disease that results in insufficient number of evaluable lumbar vertebrae, or \>1 lumbar vertebral fracture in L1-L4;
* More than 4 vertebral fractures in T4-L4;
* Bilateral hip replacements;
* Use of fluoride (e.g. fluoride therapy for osteoporosis) or strontium at any time;
* Have received methotrexate or immunomodulatory agents with antiproliferative activity;
* With known dermatological disorders that would interfere with the study procedures or assessments, or with a history of contact dermatitis;
* With known allergy or sensitivity to tapes, adhesives, PTH, teriparatide or its analogs, or components of the Macroflux® systems;
* Who, in the opinion of the investigator, should not participate in the study, or may not be capable of following the study schedule for any reason; and
* Unwillingness or inability to abide by the requirements of the study.
* Have received any intravenous (IV) administered bisphosphonates in the past 24 months, or \>2 doses of IV administered bisphosphonates total;
* Use of oral bisphosphonates before randomization, including investigational bisphosphonates, unless: \<6 months of treatment and off for 6 months, or 6-12 months of treatment and off for 2 years, or \>12 months of treatment and off for 5 years;
Sevoflurane Versus Propofol in Endovascular Coiling of Cerebral Aneurysm

The goal of this observational study is to learn about the anti-inflammatory effects of anesthetics on patients undergoing endovascular coiling of cerebral aneurysm. The main question it aims to answer is:

Does sevoflurane or propofol affect the inflammatory response in subarachnoid hemorrhage?

Participants already undergoing endovascular coiling of cerebral aneurysm will have their serum levels of inflammatory factors measured.


Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients aged 18 years and older presenting to the Tongji hospital for endovascular coiling of cerebral aneurysm were eligible for enrollment.

Exclusion Criteria:

* have an endocrine system disease
* pregnancy
* have other brain disorders
* take drugs that alter endocrine hormones
* receive perioperative blood derivatives
The Effect of Dexmedetomidine for Suprascapular Nerve Block With Axillary Nerve Block

Suprascapular nerve block (SSNB) is most commonly used for relieving postoperative pain of arthroscopic rotator cuff repair and it can be used in combination with axillary nerve block (ANB). Dexmedetomidine (DEX) is known as a type of alpha agonist which can elongate the duration of regional block. The aim of this study was to compare the results of dexmedetomidine combined with SSNB and ANB with SSNB and ANB alone on postoperative pain, satisfaction, and pain-related cytokines within the first 48 hours after arthroscopic rotator cuff repair.

Forty patients with rotator cuff tears who had undergone arthroscopic rotator cuff repair were enrolled in this single center, double-blinded randomized controlled trial study. Twenty patients were randomly allocated to group 1 and received ultrasound-guided SSNB and ANB using each mixture of 0.5 ml (50 μg) of DEX and 9.5 ml of 0.75% ropivacaine preemptively. The other 20 patients were allocated to group 2 and underwent ultrasound-guided SSNB and ANB alone using a mixture of 0.5 ml of normal saline and 9.5 ml of ropivacaine. The visual analog scale (VAS) for pain and patient satisfaction (SAT) scores were checked within 48 h postoperatively. The plasma interleukin (IL)-6, -8,-1β, cortisol, and serotonin levels were also measured within 48 h postoperatively.


Eligibility Criteria:
Inclusion Criteria:

* defined rotator cuff tear on preoperative MRI, which indicated repair
* acceptable arthroscopic surgery, including rotator cuff repair
* patients \>20 years old
* acceptable routine regional blocks and patient-controlled analgesia (PCA)

Exclusion Criteria:

* did not undergo arthroscopic rotator cuff repair
* stopped PCA before 48 h postoperatively due to side effects
* had a concomitant operation for a Bankart lesion
* had a history of shoulder operation or fracture
* had a concomitant neurological disorder around the shoulder
* underwent conversion to open surgery from the arthroscopy
* had contraindications for the routine regional blocks used in this study
* had an known allergy or hypersensitivity against ropivacaine or dexmedetomidine, including other amino-amide local anesthetics or α2-adrenoceptor agonists.