cyrilzakka/clinical-trials huggingface dataset:
A Study of FG-3019 in Subjects With Liver Fibrosis Due to Chronic Hepatitis B Infection

The overall goal of this trial is to evaluate the efficacy of FG-3019 for reversing liver fibrosis in subjects with chronic hepatitis B infection who are beginning antiviral therapy with entecavir. This Phase 2 randomized, double-blind, placebo controlled study will enroll subjects with chronic active hepatitis B infection and liver fibrosis (Ishak score ≥2) who are eligible for antiviral therapy.


Eligibility Criteria:
Inclusion Criteria

* Signed informed consent
* Age of 18 to 75 years, inclusive
* HBsAg positive for ≥24 weeks prior to screening
* Liver fibrosis, confirmed by biopsy and histology
* Willing to use contraception

Exclusion Criteria:

* Female subjects who are pregnant or nursing
* Prior antiviral therapy, with the exception of interferon therapy \>6 months prior to Day 1
* Severe heart failure
* Present hepatocellular carcinoma and history of other cancers
* Severe anemia
* Advanced kidney disease
* Immunosuppressive therapy within 24 weeks prior to screening
* Alcohol or drug abuse within the 12 months prior to screening
* Trauma or surgical procedures requiring hospitalization within 8 weeks prior to Day 1
* Planned elective surgery during the study including 9 weeks following the final dose of study drug
* History of allergy against nucleoside analogs or human, humanized, chimeric, or murine monoclonal antibodies
* Inability to cooperate with study personnel or a history of noncompliance to the medical regimen (i.e., subjects who would be expected to comply poorly with the treatment)
* Clinically significant medical or psychiatric condition considered a high risk for participation in an investigational study
* Morbid obesity (body mass index \[BMI\] \>40)
* Inadequate IV access
Acute Subcutaneous SemaglutidE in Acute Ischemic sTroke

Can Semaglutide help reduce the damage caused by a stroke? ASSET trial is a national, multicenter, clinical trial, investigating the safety and efficacy of Semaglutide in non-diabetic patients with acute ischemic stroke.

Stroke is a worldwide leading cause of long-term disability and death. In the most common type of stroke (ischemic stroke), a blood clot obstructs an artery in the brain, and thereby prevents oxygenated blood from reaching an area of the brain. Brain cells are particularly vulnerable to the lack of oxygen. In the areas most severely affected by a stroke, brain cells die after 5 minutes. As more time pass, the affected area expands, and more brain cells perish. Today, efficient treatments aiming at reestablishing the flow of blood by either breaking down the blood clot (thrombolysis) or removing the clot (thrombektomi) are used. However, a significant amount of patients undergoing succesful treamtent, still suffer permanent disability following an ischemic stroke.

Semaglutide mimics a naturally occurring hormone (glucagon-like peptide-1) and is currently used to treat diabetes and obesity. However, semaglutide has also been shown to possess neuroprotective abilities in recent animal studies, where it reduced the damage caused by ischemic stroke in rats. This study sets out to investigate if it's possible to utilize Semaglutide, to increase the resilience of brain cells in patients with an acute ischemic stroke, with the aim of bettering their outcome.

The participants consist of non-diabetic patients with acute ischemic stroke, who will be randomized to:

* Treatment with subcutaneous Semaglutide, or
* No additional treatment (control group)

Both groups will be treated according to the standard national guidelies for acute ischemic stroke.

The two groups will then be compared to see, if patients in the group treated with Semaglutide are less impacted by their stroke.

For detailed project description, please refer to the full trial information at the Clinical Trials Information System (see 'More information' below for link).

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients (≥ 18 years) at the time of signed informed consent/proxy consent
* Acute ischemic stroke with disabling neurological deficits (defined as an impairment of one or more of the following: language, motor function, cognition, gaze, vision, neglect, or ataxia)
* Onset/last seen well to randomization \< 4.5 hours
* None to moderate disability in daily living before symptom onset (pre-stroke modified Rankin Scale 0-3)

Exclusion Criteria:

* Diabetes (known) or plasma/point of care test-glucose \>11.1 mmol/L at admission
* BMI\< 22
* History of pancreatitis, medullary thyroid carcinoma
* Predisposition or known Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
* Short remaining life expectancy (\< 12months) and/or severe neurodegenerative disease
* Pregnancy or planned pregnancy within 12 months or breastfeeding
* Renal impairment measured as estimated glomerular filtration rate (eGFR) value of \<30 mL/min/1.73 m2
Clinical Evaluation of a Restorative Glass Ionomer and a Bulk-fill Composite Resin

The clinical performance of a restorative glass ionomer and bulk-fill resin composite in class II restorations will be evaluated and compared. After recruiting participants with at least 2 approximal caries lesions, all restorations will be placed by a single clinician. All caries lesions will be removed before restoring. Cavities will be divided into two groups: a restorative glass ionomer \[Equia Forte HT, GC, Tokyo, Japan (EHT)\] and bulk-fill composite resin \[SonicFill2, Orange, CA, USA (SBF)\] All restorative procedures will be conducted according to manufacturers' instructions. Restorations will be scored using modified United States Public Health Service (USPHS) criteria after a week (baseline) 6, 12, 24, 36 and 48 months. Descriptive statistics will be performed using chi-square tests.


Eligibility Criteria:
Inclusion Criteria:

* age range will be 18 to 65
* patients should have at least 2 approximal caries lesions require restoration
* healthy periodontal status
* a good likelihood of recall availability

Exclusion Criteria:

* poor gingival health
* adverse medical history
* potential behavioral problems
Indoleamine 2,3-dioxygenase (IDO) Activity in Patients With Chronic Lymphocytic Leukemia (CLL)

The Activity of Indoleamine 2,3-dioxygenase in patients with Chronic Lymphocytic Leukemia (CLL) is studied.

The Activity of Indoleamine 2,3-dioxygenase in patients with Chronic Lymphocytic Leukemia (CLL)is studied in patients and healthly controls.

Eligibility Criteria:
Inclusion Criteria:

* Patients with CLL and lymphocyte count \> 10 x 109/l

Exclusion Criteria:

* Acute infection
Multisite Tissue Oxygenation Guided Perioperative Care in Cardiac Surgery

The BOTTOMLINE-CS trial is an international, open, single-center, pragmatic, randomised controlled trial to investigate whether multisite tissue oxygen saturation monitoring-guided perioperative care reduces composite complications within 30 days of randomization in off-pump coronary artery bypass grafting.

Short title: BOTTOMLINE-CS trial Methodology: International, open, single-center, pragmatic, randomised controlled trial Research sites: Tianjin Chest Hospital Objectives: To investigate whether multisite tissue oxygen saturation monitoring-guided perioperative care reduces composite complications within 30 days of randomization in off-pump coronary artery bypass grafting Number of patients: 1960 patients (980 per arm, two arms) Inclusion criteria: Patients aged ≥ 60 years undergoing elective off-pump coronary artery bypass grafting Exclusion criteria: Patient refusal, clinician refusal, preoperative requirement of respiratory support (intubation, CPAP or BiPAP, or high-flow oxygen (\>10 L/min)), preoperative requirement of external cardiac assist devices, emergent or urgent surgery, patients expected to die within 30 days, current participation in another clinical trial Statistical analysis: Analyses will be performed on a modified intention-to-treat basis including all randomized patients who had undergone the scheduled surgery and had the record of the primary outcome. Summary statistics for each group, treatment effects, 95% confidence intervals, and p values will be presented for primary and secondary outcomes, and process measures. The primary outcome is a composite of complications arising within 30 days from randomization and will be analyzed using a logistic regression model.

Proposed start date: May 1, 2021 (First patient to be recruited) Proposed end date: April 30, 2023 (Last patient to be recruited) Study duration: 48 months (Starting from the first patient recruitment, spanning patient recruitment, data analysis, and manuscript writing and submission)

Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥ 60 years scheduled for elective off-pump CABG.

Exclusion Criteria:

* Inability or refusal to provide consent of participation
* Preoperative requirement of respiratory support (intubation, CPAP or BiPAP, or high-flow oxygen (\>10 L/min))
* Preoperative requirement of external cardiac assist device
* Urgent or emergent surgery
* Patients expected to die within 30 days of randomization
Effects of Dietary Protein Intake From Beef/Pork and Soy/Legumes on Appetite, Mood, and Weight Loss

The primary aims of this study are to assess the effects of habitual dietary protein intakes across the acceptable macronutrient distribution range with lean beef/pork or soy/legumes as the predominate sources of protein on indices of daily appetite and mood, and on postprandial appetite, mood, energy expenditure, and glycemic responses during energy-restricted weight loss in overweight adults.


Eligibility Criteria:
Inclusion Criteria:

* Age range: 21 years and older
* Body mass index between 27.0-36.9 kg/m2
* Non-smoking (within the last 6 months)
* Weight stable (\< 3 kg (\~7 lbs) weight gain or loss within last 3 months)
* Energy need for weight maintenance 1950-2750 kcal/day
* Not dietary restrained
* Menstruating women not pregnant or lactating
* Constant habitual activity patterns (within last 3 months)
* No Acute Illness (or have chronic diseases known to influence protein or energy metabolism)
* Non-diabetic
* Clinically normal blood profiles (within 10% of clinical normalcy)
* Non-hypertensive
* Not taking medications known to influence appetite or metabolism
* Willingness to eat study foods
* Able to travel to testing facility

Exclusion Criteria:

* Age: \<21 years
* Body mass index: outside of the 27.0-36.9 kg/m2 range
* Smoker (currently or within the last 6 months)
* Gained or lost \> 3.0 kg (7 lbs) within the last 3 months
* Energy need for weight maintenance \< 1950 or \> 2750 kcal/day
* Dietary restrained (≥ 14 on Three Factor Eating Questionnaire)
* Pregnant, lactating, or non-menstruating women
* Clinically diagnosed as a diabetic, or with liver or kidney disease/dysfunction, or osteoporosis
* Clinically abnormal blood profiles as identified by our study physician, Arthur Rosen, MD
* Hypertensive
* Taking medications (currently or within the last 3 months) known to influence appetite or metabolism
* Allergies to eggs
* Lactose intolerance
* Unwillingness to eat study foods
* Inability to travel to testing facility
A Study of Experimental Medication BMS-986251, Taken by Mouth, in Healthy Participants and Patients With Average to Very Serious Psoriasis

The purpose of this study is to investigate experimental medication BMS-986251 taken by mouth in healthy patients and patients with average to very serious Psoriasis (a condition characterized by itchy, dry skin with a scaly rash).


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria (Healthy Patients):

* Males and females, ages 18 to 55 years, inclusive, at screening
* Healthy subjects, as determined by no clinically significant deviations from normal in medical history, physical examination, 12-lead ECGs, vital signs, and clinical laboratory results
* Body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive, at screening
* Body weight between 55 kg and 105 kg, inclusive, at screening
* Women must not be breastfeeding

Exclusion Criteria (Healthy Patients):

* Previous participation in the current study
* Participation in a drug study or exposure to any investigational drug or placebo within 2 months prior to (the first) drug administration in the current study
* Employees of PRA or the Sponsor and their relatives
* Any significant acute or chronic medical condition that presents a potential risk to the subject and/or that may compromise the objectives of the study, including active, or history of, liver disease, or intestinal disorder including irritable bowel syndrome
* Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect pharmacokinetics; history of cholecystectomy is not allowed

Inclusion Criteria (Psoriasis Patients):

* Males and females, ages 18 to 70 years, inclusive, at screening
* BMI of 18.0 to 35.0 kg/m2, inclusive, at screening
* Body weight between 55 kg and 120 kg, inclusive, at screening
* Diagnosed with stable chronic plaque psoriasis, for at least 6 months prior to screening and be candidates for either photo-therapy or systemic treatment
* Moderate-to-severe intensity of psoriasis as defined by:

  1. Affected body surface area (BSA) of ≥10%
  2. Psoriasis Area and Severity Index (PASI) ≥12
  3. Physician Global Assessment (PGA; 6-point scale) ≥3

Exclusion Criteria (Psoriasis Patients):

* Previous participation in the current study
* Participation in a drug study or exposure to any investigational drug or placebo within 2 months prior to (the first) drug administration in the current study
* Employees of PRA or the Sponsor and their relatives
* Any significant acute or chronic medical condition that presents a potential risk to the subject and/or that may compromise the objectives of the study, including active, or history of, liver disease, or intestinal disorder including irritable bowel syndrome
* Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect pharmacokinetics; history of cholecystectomy is not allowed

Other protocol defined inclusion/exclusion criteria could apply
Vascular Supply Identification, Lesion Extension and Search for Tumor Similarity at a Distance by VTM in Breast Cancer

When we talk about early identification, we are talking about an ALREADY EXISTING INJURY, triggering a change in the patient's quality of life and a projection of future costs for the health system.

INNOVATIVE ASPECT: While screening mammography identifies an existing lesion, VTM could: Make an early diagnosis before the formation of a visible or palpable tumor mass; Check the metabolic activity in suspicious lesions identified by other diagnostic methods; Demarcate tumor range and tumor similarity from a distance in breast cancer.

Regarding the Risk x Benefit:There are no medications incorporated, associated or administered by the equipment; There is no ionizing radiation incorporated or delivered by the equipment; There are no contraindications for the use of the equipment by the patient (Non-ionizing infrared radiation, without contrast or contact); Audience destined to operate the equipment: Physician / Radiologist with training Therefore, the research in question is of great relevance for such a debilitating health problem for the patient and for the health system.

Breast cancer control has been one of the priorities on the agenda of the National Health Policy in Brazil. Thus, the Ministry of Health, through the publication "Guidelines for the Early Detection of Breast Cancer in Brazil", recommends the identification of the disease in its early stages through early detection strategies. It is estimated that there will be 66,280 new cases of breast cancer for each year of the three-year period 2020-2022 in Brazil and Population-Based Cancer Registries (RCBP), Hospital Cancer Registries (RHC) and information on Mortality are essential requirements for national and regional programs for cancer control, in addition to guiding the research agenda.

According to the National Cancer Institute (INCA), the benefit of screening mammography is in early identification, allowing for less aggressive treatment.

VTM is a functional method that demonstrates the metabolic intensity in real time, through images in the colors of the visible spectrum without using ionizing energy or contrast. It expresses metabolic alterations before anatomical transformations. It is a method without radiation, contrast, pain or contact, and can be used without limiting the exposure time.

Eligibility Criteria:
Inclusion Criteria:

Women ≥18 years old; Women with breast cancer before oncological treatment; Voluntary signature of the Free and Informed Consent Term.

Exclusion Criteria:

Pregnant or lactating women; Patients already included in other clinical trials; Patients who are undergoing radiotherapy, chemotherapy or post-cancer surgery treatment; Patients who need urgent or emergency care; Patients with fever or other illness that affects the integrity of the skin; Any clinically significant medical condition or medical history that, in the opinion of the investigator, may discourage participation in the study.
Single Arm Trial of Tumor-Treating Fields in Combination With Nivolumab and Ipilimumab in Metastatic Uveal Melanoma

Tumor Treating Fields targeted to liver metastases may improve outcomes for patients with metastatic uveal melanoma treated with immune checkpoint inhibitors.

Uveal melanoma is the most common ocular malignancy for adults and despite effective therapies, roughly 50% of patients will develop metastatic disease. Currently there is no therapy to improve the prognosis of patients with metastatic disease and these patients are usually treated with regimens used for cutaneous melanoma. Tumor Treating Fields is a new type of anti-cancer therapy approved by the FDA for use in glioblastoma multiforme and mesothelioma. TTF has been shown to activate the STING pathway leading to increased levels of dendritic cells in regional lymph nodes.

Eligibility Criteria:
Inclusion Criteria:

1. Patient has histologically or cytologically confirmed metastatic uveal melanoma with predominant liver involvement
2. Age 18 years or older and willing and able to provide informed consent
3. WOCBP must have a negative serum pregnancy test documented with 72 hours of first administration of drug
4. Sexually active and WOCBP, patient and partner must agree to use adequate contraception
5. Normal organ and marrow function
6. ECOG 0-1
7. Life expectancy of 3 months or greater

Exclusion Criteria:

1. History of previous grade 3, life threatening immune related adverse event (irAE) from prior checkpoint inhibitor therapy
2. Prior treatment with anti cytotoxic T-Lymphocyte-Associated protein 4 (CTLA-4) therapy within 90 days of C1D1 of study treatment
3. Prior anti-cancer therapy (systemic, regional or radiation) within 2 weeks of C1D1 of study treatment
4. AEs from prior anticancer therapies that have not resolved to grade 1 or less, other than endocrine related irAEs for which patients are on appropriate replacement therapy (ie hypothyroidism, adrenal insufficiency, type 1 diabetes)
5. History of or active autoimmune disease requiring systemic corticosteroid or immunosuppressive therapy. (Patients who have limited autoimmune disease not requiring systemic therapy or autoimmune disease that is unlikely to recur, such as ulcerative colitis s/p colectomy, will be allowed to enroll.)
6. Serious medical risk factors involving any of the major organ systems such that the Investigator considers it unsafe for the patient to receive an experimental research drug.
7. Patient is unwilling or unable to comply with study procedures
8. Patients with implanted pacemaker, defibrillator, nerve stimulator or other active electronic medical devices; sensitive to conductive hydrogels used on electrocardiogram (ECG) stickers or transcutaneous electrical nerve stimulation (TENS) electrodes typically used for TTFields studies.
Sarcoid Genetic Analysis (SAGA)

To identify sarcoidosis susceptibility genes and to determine how these genes and environmental risk factors interact to cause sarcoidosis.

BACKGROUND:

Sarcoidosis is a rare systemic granulomatous disease that mainly affects young to middle aged adults, and more severely affects African Americans than Caucasians. The etiology of sarcoidosis is not yet known, and epidemiological studies have only identified general risk factors including age, sex, race, and family history. Sarcoidosis may also be influenced by environmental factors, although the particular environmental agents have not yet been clearly defined. While previous studies have provided evidence for familial clustering, little is known about the genes that influence predisposition to sarcoidosis.

DESIGN NARRATIVE:

This is a multicenter consortium genetic epidemiology study. The investigators will accomplish their goal by organizing a 10-site multi-center consortium to recruit an adequate sample of sarcoidosis families for analysis. They plan to use the affected sibling pair linkage analysis to scan the genome for linked chromosomal regions, transmission disequilibrium testing to evaluate candidate genes in those regions with evidence for linkage, and an environmental questionnaire to collect data to test for possible interactions of susceptibility genes with exogenous risk factors. Genotyping and analysis of data are scheduled to begin in July, 2001 with completion of all analysis by April, 2004.

The study consists of a Clinical Core, a Data Coordinating Core, and a Genetics Core with a DNA Processing Center and a Genotyping Center. Eight of the ten clinical centers comprising the Clinical Core are members of the ACCESS, A Case Control Etiology of Sarcoidosis Study.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Healthy Aging Through Dietary Intervention

To test the impact of flavanol supplementation of cardiac and vascular function and subsequently on exercise capacity in elderly individuals


Eligibility Criteria:
Inclusion Criteria:

* age 50-79

Exclusion Criteria:

* non-cardiac limitations of exercise capacity such as orthopedic or neurological disorders, BMI \>35 kg/m2, active smoking, uncontrolled blood pressure, diabetes, COPD, atrial fibrillation, cardiomyopathy, coronary heart disease, valvular heart disease, cardiac pacemaker, acute respiratory tract infections, missing ability or missing cooperation to participate in the study