cyrilzakka/clinical-trials huggingface dataset:
Study of ARO-RAGE in Healthy Subjects

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single- and multiple-ascending doses of ARO-RAGE Injection in normal healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Normal pulmonary function tests at Screening prior to sputum induction
* Normal 12-lead electrocardiogram (ECG) at Screening
* Non-smoking
* Able to produce an induced sputum sample at Screening
* Participants of child-bearing potential (male and female) must use highly effective contraception and cannot donate sperm or eggs during the study or for at least 12 weeks following the end of the study or last dose of study drug, whichever is later. Women must have a negative pregnancy test and cannot be breastfeeding
* Willing to provide written informed consent and to comply with study requirements

Exclusion Criteria:

* Acute lower respiratory infection within 30 days prior to first dose and/or acute upper respiratory infection within 7 days prior to first dose
* Positive COVID-19 test during Screening window
* Chronic or acute infection that is clinically significant or requires treatment with systemic antibiotics, antivirals, antifungals, or antiparasitics within 30 days prior to first dose
* Any history of chronic pulmonary disease
* Use of immunosuppressive medication within 90 days prior to first dose
* Receipt of any intranasal vaccine within 30 days prior to first dose
* Human Immunodeficiency virus (HIV) infection, seropositive fo Hepatitis B Virus (HBV), seropositive for Hepatitis C Virus (HCV)
* Uncontrolled hypertension
* Use of illicit drugs
* Unwilling to limit alcohol consumption to within moderate limits for the duration of the study
* Use of an investigational agent or device within 30 days prior to first dose
* Prior use of any formulation of ARO-RAGE

Note: additional inclusion/exclusion criteria may apply per protocol
Effects of Dietary Nitrate Intake on Cardiovascular Performance in Response to Hand Grip Test in Bodybuilders

Through a randomized, crossover, double-blind, placebo-controlled clinical trial, 20 bodybuilders will participate a acute-day trial with two intervention protocols: 1) placebo and 2) nitrate; in which will ingest beet juice with or without NO3 in its composition with a 7-day washout interval.


Eligibility Criteria:
Inclusion Criteria:

* Anabolic steroid use in the past or actually;
* Participation at least one bodybuilding competition;

Exclusion Criteria:

* Previous history of acute myocardial infarction and/or stroke;
* Allergy or intolerance to nitrate, gluten, or milk;
* Medications (proton pump inhibitors, beta-blockers, calcium channels antagonists).
Effect of Wet Cupping Versus Moderate Intensity Aerobic Exercise on Inflammatory Markers in Diabetic Patients

Among all pro-inflammatory biomarkers, TNF-α first recognized to be involved in the pathenogenesis of insulin resistance, and glucose-related abnormalities that link to T2DM. TNF-α plays a vital role in the overall pathophysiology of insulin resistance especially in males with greater body mass index as compared to that in the females This trial aims to investigate the effect of wet cupping therapy versus moderate intensity aerobic exercise on inflammatory markers in diabetic patients

Cupping therapy is a traditional treatment used to create suction on the skin over a painful area or acupuncture point using a bamboo or glass cup. Aerobic exercise (also known as endurance activities, cardio, or cardio-respiratory exercise) is physical exercise of low to high intensity that depends primarily on the aerobic energy-generating process. Chronic inflammation, including elevated levels of interleukin 6 (IL-6), is associated with diabetes, cardiovascular disease, and chronic kidney disease, as well as related diseases such as nonalcoholic hepatosteatosis. Amongst other triggers, elevated IL-6 levels may arise due to excess adipose tissue and can cause, for example, aberrant glucose metabolism leading to diabetes and other manifestations of the ensuing glucotoxicity in many tissues and organs, including the vasculature and other parts of the heart and the kidneys, as well as in the liver. The purpose of this study was to investigate the effect of wet cupping therapy versus moderate-intensity aerobic exercise on inflammatory markers in diabetic patients.

Eligibility Criteria:
Inclusion Criteria:

* had diabetes more than 10 years ago
* body mass index of 25 to 29.9 Kg/m2

Exclusion Criteria:

* Hepatic diseases, Cancer patients, Renal failure patients, Orthopedic problems or fractures of extremities, hypertensive patients, and Neurological problems
Endocrine and Emotional Effects of Lisdexamfetamine and d-Amphetamine.

The study will compare the acute emotional and endocrine effects of equivalent doses of lisdexamfetamine and amphetamine in healthy subjects. In addition the pharmacokinetics and effects of the amphetamines on aspects of social cognition are investigated.


Eligibility Criteria:
Inclusion Criteria:

healthy subjects aged 18-45 years

Exclusion Criteria:

1. Chronic or acute medical condition including clinically relevant abnormality in physical exam, laboratory values, or ECG.
2. Current or previous psychotic or major affective disorder
3. Psychotic or major affective disorder in first-degree relatives
4. Prior illicit drug use (cannabis) more than 5 times or any time within the previous 2 months.
5. Pregnant or nursing women.
6. Participation in another clinical trial (currently or within the last 30 days)
7. Use of medications that are contraindicated or otherwise interfere with the effects of the study medications (monoamine oxidase inhibitors, antidepressants, sedatives etc.)
8. Tobacco smoking (\>10 cigarettes/day)
A Phase 2 Pilot Study of Apixaban for the Prevention of Thromboembolic Events in Patients With Advanced (Metastatic) Cancer

The purpose of this study is to learn whether apixaban is well-tolerated and acceptable as anticoagulant therapy, when administered to patients with advanced or metastatic cancer and at increased risk for venous thromboembolic events. Demonstration of a favorable benefit:risk profile could lead to significant reduction in this serious and sometimes fatal complication of ongoing cancer and its treatment.


Eligibility Criteria:
Key Inclusion Criteria:

* Recipients of either first- or second-line chemotherapy for advanced or metastatic lung, breast, gastrointestinal, bladder, ovarian, or prostate cancer or myeloma, selected lymphomas, or cancer of unknown origin
* Able to begin study medication ≤6 weeks of starting either first- or second-line chemotherapy.
* Expected course of chemotherapy must have been ≥ 90 days after the start of chemotherapy
* Per Protocol Amendment 5, patients receiving bevacizumab were eligible to participate, provided that bevacizumab was used for indications approved by local country law

Key Exclusion Criteria:

* Women who are pregnant, breastfeeding
* History of deep vein thrombosis or pulmonary embolism
* Active bleeding or at high risk of bleeding
* Metastatic brain cancer
* Familial bleeding diathesis
* Serious hemorrhage requiring hospitalization, transfusion, or surgical intervention within 4 weeks of study entry
* Expected survival \<6 months or an Eastern Cooperative Oncology Group performance status ≥3.
* Candidates for bone marrow transplantation within the 12-week treatment period or 30-day follow-up period
* Uncontrolled hypertension (systolic blood pressure \>200 mm Hg and/or diastolic blood pressure \>110 mm Hg
* Coagulopathy (international normalized ratio \>1.5 or platelet count \<100\*10\^9/L) if not yet receiving chemotherapy or \<50\*10\^9/L if receiving chemotherapy). Platelet count must have been \>100\*10\^9/L before starting study medication
* One or more of the following: alanine aminotransferase \>3 times the upper limit of normal (ULN), total bilirubin \>2\*ULN, or calculated creatinine clearance \<30 mL/min.
Radiological vs Clinical Outcome in DRF

Background: Several studies have investigated the degree of final displacement and its association with clinical outcome. There is still no consensus on the importance of radiological outcome and published studies do not use the same criteria for an acceptable alignment. Previous reports have used a linear or a dichotomized exposure in the statistical analysis, but no study has investigated a nonlinear association.

Methods: We included 438 patients treated for a distal radius fracture (DRF) with either reduction and cast immobilization or surgery. Radiographic outcomes were determined by radiographs 3 months after the injury. Clinical outcome was determined by QuickDASH (qDASH), ROM and grip strength at 1-year after the injury. Nonlinear correlations were analysed with cubic splines.


Eligibility Criteria:
Inclusion Criteria:

- Patients with distal radius fracture between 15 and 74 years, with closed physes of the distal radius and ulna.

Exclusion Criteria:

* Dementia
* Previous fracture to the ipsilateral wrist
* Open fracture
* Other concomitant or existing damage or injury to the wrist
* Galeazzi fracture
* Rheumatoid arthritis
* Alcohol or drug abuse
* Neurologic impairment
Retrospective Study to Determine Effect of Rebif and Tecfidera on Infections and Lymphocytes

This study will be a single center, retrospective, pilot study to determine the effect of Rebif (interferon beta-1a) and Tecfidera (dimethyl fumarate) on infections on total lymphocyte counts, grade of lymphopenia, Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) counts and ratios in subjects aged 50 years and above with Relapsing-Remitting Multiple Sclerosis (RRMS).


Eligibility Criteria:
Inclusion Criteria:

* RRMS subjects who have been treated with interferon beta 1a SC 44 micro-gram thrice a week and dimethyl fumarate in inpatient or outpatient settings during the period from January 1, 2015 to December 31, 2015.
* Subjects with at least one year of laboratory values post-index date to analyze lymphocyte counts, and CD4 and CD8 counts. The date of first blood draw for laboratory tests after January 1, 2015 will be defined as the subject's index date.

Exclusion Criteria:

- Subjects who have been on treatment for less than 1 year after their index date.
Ghrelin, Growth Hormone and Cortisol Interaction in Growth Hormone Deficient Patients

In growth hormone deficient patients: Determination of endogenous circulating ghrelin levels, ghrelin effects on insulin sensitivity, appetite, energy metabolism, and signal transduction in fat and muscle.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 60 yrs.
* Verified hypopituitarism
* Unchanged substitution treatment through 3+ months
* Unchanged additional medical treatment
* Oral and written informed consent

Exclusion Criteria:

* Age below 18 or above 60 yrs.
* Diabetes mellitus
* body mass index \> 30
* Fasting hypoglycemia
* Convulsions
* Allergy to trial products
Long-term Follow-up of Anal Fistula Plug

Aim of the study is to evaluate long-term success rate of Biodesign® anal fistula plug for treatment of complex trans-sphincteric anal fistulas.

A prospective series of 95 consecutive patients (30 with inflammatory bowel disease) treated with Biodesign® plug in May 2006 - October 2009. All patients were preoperatively assessed by physical examination and 3D endoanal ultrasound, and treated with a loose seton. The patients were assessed by physical examination and 3D endoanal ultrasound at 2 weeks, 3 months, and 6 to 12 months after surgery. Long-term follow-up was carried out using a questionnaire, and, when indicated, physical examination and 3D endoanal ultrasound.

Eligibility Criteria:
Inclusion Criteria:

* complex transsphincteric anal fistula

Exclusion Criteria:

* ano/rectovaginal fistula
Database and Calibration of a Non-invasive Glucose Monitoring Device

This clinical study has been launched to collect spectral raman data paired with validated glucose reference values in private homes of subjects.

Subjects will collect 2-4 daily optical raman readings paired with capillary Blood Glucose comparator in own home with maintaining usual routines. Subjects will either collect data for 30 days during a 60 days period or collect data for 90 days during 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects 18 years of age or older
* Diabetic (all types) patients

Exclusion Criteria:

* Pregnant women
* Subjects not able to understand and read Danish
* In investigator's opinion, subject is not able to follow instructions as specified in the protocol
* Subjects not able to hold hand/arm steadily
* Extensive skin changes, tattoos or diseases on probe application site
* Rejection by prescreening optical measurements
* Known allergy to medical grade alcohol used to disinfect skin
Early Diabetes Resolution After Weight Loss Surgery

The primary objective is to compare inflammatory, hormonal, and metabolic changes in the very short term after various bariatric surgical procedures (Roux-en Y Gastric Bypass, Vertical Sleeve Gastrectomy, and Adjustable Gastric Banding)and other abdominal surgeries, as well as to compare these changes to diet-induced changes in the same population.


Eligibility Criteria:
Inclusion Criteria for surgery groups:

* BMI of 30 kg/m2 or higher
* Ages 18-65
* History of impaired glucose tolerance or T2DM

Inclusion Criteria for normal weight group:

* BMI of 30 kg/m2 or lower
* Ages 18-65

Exclusion Criteria:

* Development of an intercurrent infection
* Prior gastric, duodenal, proximal jejunal surgery or pancreas resection
* Current use of thiazolidinediones
* Current use of dipeptidyl peptidase-IV inhibitors (e.g., sitagliptin) or glucagon-like peptide-1 analogs (e.g., exenatide)
* Any condition felt by the PI or co-investigators to interfere with ability to complete the study
Risk Prediction Model for Cerebrovascular Events in Carotid Artery Stenosis

Atherosclerotic carotid artery stenosis is a major cause of stroke, and early identification of high-risk patients combined with surgical intervention can significantly reduce stroke risk. Currently, stroke risk assessment in patients with carotid artery stenosis primarily relies on imaging indicators such as plaque morphology, composition, and degree of stenosis, with less emphasis on indicators directly related to inflammation, hemodynamics, and plaque instability. Certain circulating metabolites are closely linked to plaque progression and are direct risk factors for stroke. However, there is a lack of stroke risk prediction models for patients with carotid stenosis that incorporate these indicators, and the ability to identify high-risk patients needs improvement.

This study proposes using deep learning technology to integrate multidimensional data from plaque imaging, fluid dynamics, circulating metabolomics, and proteomics to construct an accurate prediction model for cerebrovascular events in patients with carotid artery stenosis. Additionally, it aims to explore markers of plaque instability characteristics based on plaque pathology. The study is expected to provide a basis for identifying high-risk patients with carotid artery stenosis, thereby laying the foundation for reducing stroke risk and improving long-term patient outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with atherosclerotic carotid stenosis;
* Those who signed informed consent and volunteered to participate in this study.

Exclusion Criteria:

* Patients with combined severe stenosis of intracranial arteries;
* Patients with combined cardiogenic embolism, vasculitis, entrapment aneurysm and other related cerebral infarction;
* Combination of tumors, rheumatic immune system diseases, hematologic diseases and other diseases that change blood metabolism and proteomic characteristics;
* There are contraindications to magnetic resonance scanning and allergy to gadolinium contrast agent;
* Inability to cooperate in completing the relevant examinations.
Haemodynamic Changes During Anaesthesia in the Prone Position, Evaluated Using Transoesophageal Ultrasound

Transoesophageal ultrasound examination before and after prone position.

Patients undergoing spinal surgery in the prone position are anaesthetized and then an ultrasound probe is placed in the oesophagus and the heart physiology is examined. Following prone position the examination is repeated.

Eligibility Criteria:
Inclusion Criteria:

* adult patients scheduled for spinal surgery in the prone position. Body mass index above 30.

Exclusion Criteria:

* significant cardiomyopathy or valvular disease
* heart rhythm other than normal sinus rhythm
* coagulopathy
* increased risk of oesophageal injury during probe insertion
Investigating Age-dependent Effects of Egg Intake on HDL and Immune Profiles

The goal of this intervention study is to determine whether consumption of different fractions of chicken eggs, including egg whites, egg yolks, and whole eggs, confer different changes in markers of HDL function and T cell profiles in younger vs. older men and women. The study will address the following objectives:

* Objective 1: Determine if daily consumption of egg fractions differentially alter HDL profiles across age groups.
* Objective 2: Determine if daily consumption of egg fractions differentially alter immune cell profiles across age groups.

Participants will be asked to consume egg whites, egg yolks, and whole eggs on a daily basis for 4-weeks each, and avoid eating eggs for a total of 8 weeks at different points in the study. Participants will additionally be provided guidance on following a generally healthy diet, and will be asked to complete surveys about dietary intake and physical activity, as well as provide blood samples throughout the course of the study.

Researchers will compare whether daily consumption of egg whites, egg yolks, and whole eggs differentially alter markers of HDL function and T cell profiles in younger vs. older adults.


Eligibility Criteria:
Inclusion Criteria:

* 18-30 years old, or 50-75 years old (at time of screening)
* Body mass index (BMI) \< 30 kg/m2
* Willing to consume whole eggs, egg whites, or egg yolks on a daily basis during study periods, and refrain from eating eggs during other study periods
* Do not fit any exclusion criteria

Exclusion Criteria:

* \< 18 years old; 31-49 years old; \> 75 years old
* BMI ≥ 30 kg/m2 or body weight \< 110 pounds
* Weight changes \> 10% over the last 4 weeks
* Self-reported history of diabetes, heart disease, stroke, renal or liver disease, cancer, eating disorders, certain severe and/or relapsing/remitting autoimmune, inflammatory, or metabolic diseases, chronic infections, scleroderma, blood clotting disorders, intravenous drug use, or current pregnancy or lactation
* Allergy or intolerance to eggs, egg components, or egg products
* Implanted medical device (e.g., pacemaker) or other health condition that would prevent measurement of body composition by bioelectrical impedance
* Highly elevated fasting lipid and glucose levels (triglyceride levels higher than 500 mg/dL, fasting glucose higher than 126 mg/dL), or total cholesterol \< 120 mg/dL and HDL-cholesterol \< 15 mg/dL
* Currently taking lipid-lowering medications (e.g. statins, fibrates), anti-inflammatory medications (e.g., NSAIDs, corticosteroids), or medications that primarily affect blood clotting (e.g., warfarin)
Open-Label Program of Dideoxycytidine ( ddC ) to Be Used in Combination With Zidovudine ( AZT ) for Treatment of Advanced HIV Disease

To provide zalcitabine ( dideoxycytidine; ddC ) for use with zidovudine ( AZT ) in patients with advanced HIV infection. To observe serious toxicities in this population.

Patients are treated with 1 of 2 doses of ddC administered orally (PO) in combination with AZT administered PO (patients who are unable to tolerate this dose of AZT may receive a lower dose).

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Concomitant use of investigational compounds for prophylaxis or treatment of opportunistic infections or other treatments provided use of those compounds with ddC-AZT is considered safe.

Patients must have:

* Documented HIV infection OR documented AIDS-defining opportunistic infection or neoplasm.
* Previous AIDS-defining opportunistic infection, neoplasm, or condition OR CD4 lymphocyte count equal to or less than 300 cells/mm3 if symptomatic ORCD4 lymphocyte count equal to or less than 200 cells/mm3 if asymptomatic.
* Patients must not be currently enrolled in or must be unable to enter an AIDS Clinical Trials Group (ACTG), Community Programs for Clinical Research on AIDS (CPCRA), or other controlled clinical program because of patient ineligibility, distance from trial site, or patient refusal.
* Patients currently enrolled in any controlled clinical trial of an anti-HIV compound may enter this program only if they have met the end points required for termination of that trial.
* Patients may be co-enrolled in clinical programs of investigational compounds being tested for prophylaxis or treatment of opportunistic infections or other treatments provided that program allows ddC-AZT combination use, and concomitant administration of the other investigational drug and ddC-AZT is considered safe by the investigator.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Any clinical or laboratory toxicity or abnormality, particularly the presence or history of moderate to severe peripheral neuropathy, that would pose an undue risk to the patient upon initiation of ddC-AZT treatment.
* Pregnancy.
A Phase III Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution Compared With Latanoprost Ophthalmic Solution in Subjects With OAG or OHT

The purpose of this study is to investigate the intraocular pressure-lowering effect and the safety of DE-117 ophthalmic solution compared with Latanoprost ophthalmic solution in subjects with open angle glaucoma or ocular hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Patients with open angle glaucoma or ocular hypertension in both eyes

Exclusion Criteria:

* Patients at risk of progression of visual field loss
* Patients with severe visual field defect
* Patients with any diseases that preclude participation in this study for safety reasons