cyrilzakka/clinical-trials huggingface dataset:
Efficacy/Safety of Amlodipine Plus Losartan Versus Losartan in Patients With Essential Hypertension

The purpose of this study is to evaluate of efficacy and safety of amlodipine plus losartan and losartan alone in patients with essential hypertension inadequately controlled on losartan monotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age
* Essential hypertensive patients whose blood pressure is not controlled before the study (sit DBP≥90 mmHg for drug-treated patient, sit DBP≥95mmHg for drug-naïve patient)
* Non-responder to 4 weeks treatment of losartan 100 mg monotherapy (sit DBP≥90mmHg)

Exclusion Criteria:

* mean sit SBP≥200mmHg or mean sit DBP≥120mmHg at screening
* mean sit SBP≥180 mmHg or mean sit DBP≥120mmHg after 4 weeks of losartan 100mg treatment
* has a history of hypersensitivity to dihydropyridines or angiotensin II receptor blockers
* Secondary hypertensive patient or suspected to be
* Uncontrolled diabetes mellitus patients
* Severe heart disease or severe neurovascular disease
* Known as severe or malignant retinopathy
* Patients showed clinically significant hematological finding, patients with renal diseases (serum creatinine), patients with hepatic disease (ALT or AST)
* History of malignancy tumor
* History of autoimmune disease
* History of alcohol or drug abuse
* Positive to pregnancy test, nursing mother, has an intention on pregnancy
* Considered by investigator as not appropriate to participate in the clinical study with othe reason
Diabetes Go Mobile! Pilot Study

The purpose of this study is to examine whether a behavioral lifestyle intervention using mobile smart phone technology for self-monitoring can lead to greater improvements in diabetes outcomes.

The investigators will conduct a pilot randomized controlled clinical trial to examine the feasibility and preliminary efficacy of a behavioral lifestyle intervention on weight, glycemic control, and vascular inflammatory marker outcomes. A total of 26 overweight or obese patients with type 2 diabetes will be recruited from an underserved minority community health center in Houston, TX. They were randomly assigned into one of the three groups: 1) Behavior intervention with smart phone based self-monitoring, 2) Behavior intervention with paper diary based self-monitoring, and 3) Usual care group. Both Mobile and Paper groups received a total of 11 group sessions and 1 individual session in a 6-month intervention. Mobile group received an android-based smart phone with two applications loaded to help them record their diet, physical activity, weight, and blood glucose, while the paper group is using paper diaries for these recordings.

Eligibility Criteria:
Inclusion Criteria:

* 21 to 74 years of age
* BMI≥ 25 kg/m2
* Self-reported being diagnosed with type 2 diabetes for at least 6 months
* Currently monitor blood glucose and has a blood glucose meter
* Be able to read and write in English

Exclusion Criteria:

* Previously participated in a structured lifestyle intervention, such as Look AHEAD in the last 12 months
* Current pregnant /nursing or plan to become pregnant in the next 6 months
* In addition to their diabetes condition, presence of a current serious illness or unstable condition requiring supervision on a special diet and limiting their ability to perform physical activity level.
* Current treatment for a severe psychological disorder
* Planned vacation, absences, or relocation in the next 6 months
EUS-guided PORtal Vein Sampling for Circulating Tumor Cells in Pancreatic Cancer Patients

The study aims at evaluating the feasibility and safety of EUS-guided Portal Circulation sampling for isolation, enumeration and profiling od Circulating Tumor Cells (CTC) in Pancreatic Cancer patients.

Patients undergoing Endoscopic Ultrasound (EUS) for cyto/histological characterization of the neoplasia will receive an additional Fine Needle Aspiration sampling of a branch of the Portal Circulation to obtain a blood sample which will be processed for CTC enrichment, count and characterization.

Prognostic stratification of patients with Pancreatic Ductal Adenocarcinoma (PDAC) is still suboptimal, relying only on imaging studies and Carbohydrate Antigen 19.9 to drive important treatment decisions (e.g. surgery versus neoadjuvant chemotherapy).

Circulating Tumor Cells (CTCs) have been poorly evaluated in this neoplasia as they are rarely detected in the peripheral blood, whereas they are more abundantly detected in the portal circulation below the hepatic filter.

Most PDAC patients undergo Endoscopic Ultrasound (EUS) for cyto/histological characterization of the neoplasia. EUS-guided acquisition of portal blood for CTC evaluation has demonstrated its feasibility in preliminary studies without reducing the safety of the endoscopic procedure.

The study aims at collecting portal blood from PDAC patients under EUS-guidance to evaluate whether concentration and characterization of CTCs has a prognostic significance and can aid in decision making.

A paired peripheral blood sample will be acquired for comparison. Samples will be processed to obtain microfluidic enrichment of CTCs and stained with immunofluorescent antibodies for exclusion of hematopoietic cells and specific identification of CTCs, which will then be counted to obtain the blood concentration expressed as number of cells per 7.5 ml of blood.

Patients will be followed every 60 days for a maximum of 24 months to assess the evolution of primary disease and clinical status.

Eligibility Criteria:
Inclusion Criteria:

* patient with a pancreatic solid lesion undergoing EUS with a rapid on-site confirmation of a pancreatic ductal adenocarcinoma
* patients primarily followed within San Raffaele Institute

Exclusion Criteria:

* history of active non-pancreatic cancer
* coagulopathy (INR \> 1.5; platelets \< 70.000/ul) or use of non-withdrawable anticoagulant or antiplatelet
* known history or endosonographic signs of portal hypertension
* extensive invasion of portal vein precluding needle maneuvers
* pregnancy and breastfeeding
A Multi-Center, Observational Safety Registry of Subjects With Idiopathic Parkinson's Disease Previously Treated With Intraputaminal Infusion of Liatermin

The primary purpose of this study is to evaluate clinical and serologic outcomes after the discontinuation of liatermin therapy as assessed by development of new clinical conditions beyond those expected in patients with advancing Parkinson's disease. In addition, the development or resolution of anti-r-metHuGDNF binding and neutralizing antibodies will be monitored.


Eligibility Criteria:
Inclusion Criteria: - Subjects must have a diagnosis of bilateral, idiopathic Parkinson's Disease who have been enrolled and treated with intraputaminal infusion of liatermin in a previous Amgen/Medtronic-sponsored trial (protocols 20010109 or 20030160) or the Bristol open-label study - At time of implant (Study 20030168), subjects need to have been 35 to 70 years of age
Pranayama Breathing and Uncontrolled Hypertension

This study will compare participants who have uncontrolled hypertension and perform a set of five breathing exercises (Pranayama breathing) to a control group. The purpose of the study is to determine the effect of the breathing exercises on reduction of blood pressure.

Untreated or uncontrolled hypertension is a leading cause of heart disease, stroke, and kidney failure. Hypertension, is a modifiable risk factor that may be successfully treated using one or a combination of treatment options, including medication, diet, exercise, tobacco cessation, or complementary and alternative medicine such as breathing exercises. A well-established cascade of adverse health outcomes are associated with hypertension as well as increased mortality rates. For patient-centered care, providing patients with additional strategies for their health care also has the potential to empower the patient, augment patient-physician team approach to the patient's health care, and support the standards of care for treating hypertension. As explained by McCaffrey et al from their focus group work with patients, "Participants do not want prescription medications except as a last resort and feel that conventional medicine overemphasizes prescription medicines. This may be because of a combination of factors including distrust in conventional medicine, fear of side effects from medicines, and an underlying belief that the body can heal itself given the right nutrition, rest, and time"

Using a randomized controlled trial study design with a 1-month and 3-month follow-up, the investigators hypothesize that practicing breathing at least 5 times per week will show a mean reduction in systolic (SBP) and diastolic (DBP) blood pressures in uncontrolled hypertensive patients compared to control patients. Participants will be randomized into one of three arms of the study. For the intervention arm, participants will be either assigned to a weekly class for the pranayama breathing instruction and practice or given a DVD that contains instructions on the breathing exercises and the 15-minute practice session.

Eligibility Criteria:
Inclusion Criteria

* English-speaking adults
* less than 60 years of age with BP measurements of ≥140/ ≥90 mm Hg
* 60 years of age or older with BP measurements of ≥150/ ≥90 mm Hg
* diagnosed with diabetes with BP measurements of ≥140/ ≥90 mm Hg
* Patients with BP measurements of \<180/ \<110 mm Hg without hypertensive urgency symptoms

Exclusion Criteria:

comorbidities of COPD, renal disease or chronic alcoholism

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Early Tranexamic Acid and Modulating the Inflammatory Response in Sepsis

In this study, our aim is to investigate the role tranexamic acid in modulating inflammation in patients with sepsis.

A written informed consent will be taken from the patients or their relatives.Patients will be assigned randomly to two groups (40 subjects each) with qSOFA ≥2.

In (Group T) administer 1 gram of tranexamic acid (TXA) in 100 ml of 0.9% normal saline, intravenous over 10 minutes as soon as possible but no later than three hours after diagnosis, infuse a second gram of tranexamic acid (TXA) IV over 8 hours in 0.9% normal saline for the first 3 days. In (Group C) administer the same volume (100 ml normal saline)and same duration (first three days)for controlled patients.

Eligibility Criteria:
Inclusion Criteria:

* Adults (age 18-65 years) of American society of anesthesiologists (ASA) I-II who will be diagnosed with sepsis by qSOFA ≥2
* \& needed ICU admission.

Exclusion Criteria:

* Chronic renal failure
* Liver cirrhosis
* Bleeding disorders or current anticoagulant therapy
* Pregnancy or breastfeeding
* Impaired color vision
* Severe vascular ischemia, history of venous thrombosis \& pulmonary embolism
* Long term treatment with acetylsalicylic acid or non-steroidal anti-inflammatory drugs not discontinued before ICU admission
* Allergy to tranexamic acid (TXA)
A Phase I Study of BMS-275183 (Oral Taxane) Given on a Daily Schedule in Combination With Esomeprazole (Nexium) in Patients With Advanced Cancer

The purpose of this study is to determine what effects Esomeprazole (Nexium) has on increasing or decreasing the amount of oral taxane in the blood, and to determine the safety of oral taxane and effect of oral taxane on the cancer.


Eligibility Criteria:
Inclusion Criteria:

* Advanced cancers excluding cancers within the blood
* Adequate kidney and liver function
* \> = 4 weeks from last course of chemotherapy

Exclusion Criteria:

* Inability to swallow capsules
* Other active medical disorder
* Abnormal heart function or use of drugs that affect the heart
Efficacy of Steroid Supplementation After TMJ Rinsing for Pain Management

The hypothesis to be tested is temporomandibular joint (TMJ) rinsing followed by steroid injection is more efficacious than a placebo injection based on standard pain and physical measures that are recorded before and after treatment.

All procedures will be the same as if following normal TMJ arthrocentesis (rinsing) clinical care except that the patient will be randomly assigned to one of two groups: (1) TMJ rinsing followed by the injection of 1 cc (about ¼ of a teaspoon) of the same rinsing solution (this is the placebo) into the jaw joint; or (2) TMJ rinsing followed by the injection of 1 cc (about ¼ teaspoon) of a steroid (5 mg of triamcinolone hexacetonide) into the jaw joint. A pregnancy test (urine test) will be conducted on all women of child-bearing age to verify that the patient is not pregnant before the rinsing procedure. The patient will fill out a short questionnaire and have a short exam of the TMJ and jaw muscles at each appointment.

Temporomandibular joint disorders are common and poorly understood in terms of etiology and pathogenesis. These disorders are multifactorial in origin including physical and psychosocial aspects; however, there is little understanding as to how much each of these components are associated with a particular diagnosis and subsequent treatment outcome of temporomandibular joint disorders. There is also a paucity of information regarding the relative effectiveness of different therapies for the treatment of patients with temporomandibular joint disorders. The identification of the least invasive and most efficacious therapy is vital to proper management of these patients with temporomandibular joint pain.

Patients enrolled into the study will be examined and treated at the Department of Oral and Maxillofacial Surgery. At the first appointment, they will be examined following standard procedures to determine if they would potentially benefit from the TMJ arthrocentesis procedure. If the patient meets the inclusion criteria for the study and with their informed consent, they will be required to complete a questionnaire about their physical and pain symptoms and undergo a standardized clinical exam. At the next appointment, the patients will undergo the standard clinical protocol for TMJ arthrocentesis with either only normal saline or normal saline with adjunctive steroids (triamcinolone hexacetonide). Follow-up appointments will be at 2 weeks, 6 weeks and 12 weeks where the pain VAS and clinical exams will be completed.

Eligibility Criteria:
Inclusion Criteria:

* Female
* 18-80 years of age
* TMJ arthralgia
* Masticatory myalgia
* TMJ sounds
* History of at least 6 weeks use of occlusal appliance therapy

Exclusion Criteria:

* Contraindication to sedation including pregnancy or medical history
* History of previous TMJ procedure including arthrocentesis, arthroscopy or arthrotomy
* History of steroidal injection into TMJ
* History of trauma to TMJ
* TMJ pain longer than 3 years
* History of narcotic drug use on a scheduled basis
* Current active infection
Work Interventions to Improve Employment Outcomes for Persons With Rheumatoid Arthritis and Osteoarthritis

To determine if worksite based functional evaluation/intervention provided by occupational therapists improves employment outcomes for persons with arthritis.

Arthritis is second only to heart disease as a cause of work-related disability with significant financial costs associated with the loss of work for persons with arthritis. Many persons with arthritis have physical impairments which affect their ability to work, with 50% of persons with rheumatoid arthritis leaving employment within 10 years of diagnosis. Risk factors predicting employability, length of employment and worksite accommodations for workers with arthritis have been well documented. Variables predicting work cessation include blue collar jobs and more physically demanding jobs, an older age of the worker, lower education, perceived job strain, social support of co-workers and supervisors, job satisfaction, and self-efficacy. Recent studies of self-report by persons with arthritis identified the use of worksite accommodations such as others providing assistance at work, job autonomy, time flexibility, and use of special equipment. Unknown is the effect of on-site work interventions. The need exists to determine if the provision of strategies for physical accommodations, worksite modifications, and assistive technologies at the individual's job site improves the ability of persons with arthritis to continue working.

This is a randomized clinical trial to investigate the efficacy of a worksite based intervention to improve the employment outcomes of persons with rheumatoid (RA) or osteoarthritis (OA). Persons with RA or OA who have arthritis related work difficulties will have an occupational therapist provide a worksite evaluation and subsequent training in strategies to accommodate arthritis related physical impairments and improve job performance and satisfaction. Participants in control group will be provided with educational printed materials related for a self-initiated worksite evaluation of musculoskeletal and environmental risks at the worksite for persons with arthritis.

Eligibility Criteria:
Inclusion Criteria:

* Rheumatoid arthritis or osteoarthritis diagnosed by a rheumatologist
* Competitively employed; full or part time
* Reporting arthritis-related employment difficulties
* Agree to participate in a work site evaluation

Exclusion Criteria:

* Systemic complications of RA (e.g., vasculitis)
* Organic Brain Syndrome
* Uncontrolled psychiatric disorders
* Uncontrolled medical conditions (e.g., active cancer)
BG00012 Regional Absorption Study

The primary objective of this study is to evaluate the pharmacokinetics (PK) profile of monomethyl fumarate (MMF) following delivery of BG00012 (dimethyl fumarate, DMF) 120 mg (Part 1) and BG00012 240 mg (Part 2) to varying regions within the GI tract in healthy volunteers. The secondary objective of this study is to evaluate the safety and tolerability profile following the delivery of BG00012 120 mg (Part 1) and BG00012 240 mg (Part 2) to varying regions within the GI tract in healthy volunteers.


Eligibility Criteria:
Key Inclusion Criteria:

* Healthy males or non-pregnant, non-lactating healthy females.
* Body mass index (BMI) of 18 through 35 kg/m2.
* Subjects of childbearing potential (including males) must practice effective contraception during the study and be willing and able to continue contraception for 90 days after their last dose of study treatment

Key Exclusion Criteria:

* History of or positive test result at Screening for human immunodeficiency virus (HIV), hepatitis C virus (HCV) antibody, or hepatitis B virus (defined as positive for hepatitis B surface antigen \[HBsAg\] or hepatitis B core antibody \[HBcAb\]).
* Serious infection (e.g., pneumonia, septicemia) within the 3 months prior to first dose.
* Vaccinations within 4 weeks prior to first dose.
* History of drug or alcohol abuse (as defined by the Investigator) within the previous 2 years, or regular alcohol consumption in males \>21 units per week and females \>14 units per week (1 unit = ½ pint of beer, 25 mL of 40% spirit or a 125 mL glass of wine).
* History of clinically significant gastrointestinal (GI) disease as determined by the Investigator (including Crohn's Disease, Ulcerative Colitis, confirmed diagnosis of active Irritable Bowel Syndrome).
* History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal, or other major disease, as determined by the Investigator.

NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
PrOtein and WEight Loss in teenageRs

The aim of the proposed study is to provide important data on weight loss efficacy in overweight and obese adolescents on an isocaloric higher protein diet vs a lower protein diet utilizing the U.S. Department of Agriculture (USDA) MyPlate nutrition guide. The investigators hypothesize that the higher protein diet will result in greater weight loss due to increased satiety and better dietary adherence.

Aim 1 is to test the efficacy of a personalized higher protein weight loss intervention compared to a lower protein intervention which use the USDA MyPlate nutrition guide.

It is hypothesized that participants randomly assigned to the higher protein dietary treatment will lose more weight based on BMI-Z score over 12 weeks compared to participants in the lower dietary protein treatment.

Aim 2 is to test if changes in subjective ratings of appetite differ by dietary treatment (i.e. protein intake).

It is hypothesized that participants in the higher protein intervention will report a decrease in hunger and an increase in fullness compared to participants in the lower protein intervention.

Aim 3 is to test if change in the hexosamine biosynthetic pathway (HBP) measured at the rate limiting step of glutamine fructose-6-phosphate amidotransferase (GFAT) and glycosylation measured as O-linked N-acetylglucosamine (GlcNAc) transferase (OGT) differ by dietary treatment.

It is hypothesized that participants randomly assigned to the higher protein dietary treatment will have decreased change from baseline levels of GFAT and glycosylation (OGT) due to decreased carbohydrate intake compared to the lower protein treatment.

Exploratory Aims: As exploratory aims, the investigators will test if the higher protein or lower protein dietary treatments differentially alter glucose, insulin, cholesterol, and triglycerides (markers of the metabolic syndrome).

Eligibility Criteria:
Inclusion Criteria:

* Be male or female
* Be between the ages of 12 and 17, inclusive
* Be at or above the 85th BMI percentile (a number calculated from the participants height, weight, sex, and date of birth)
* Be willing to fast for 12 hours prior to clinic study visits 2 and 4
* Be willing to participate in the research study

Exclusion Criteria:

* Health Conditions:
* Has HIV or AIDS
* Has uncontrolled CVD or arrhythmia
* Has Type I or Type II diabetes.
* Is unable or unwilling to complete the study procedures
* Participant may not qualify for this study based on other exclusion criteria not listed. The study coordinator will go over this information in detail.

Medications:

* Diuretics
* Beta-blocker
* Weight loss medications, diet pills
* Anti-inflammatory drugs (corticosteroid/anabolic steroid/NSAID)
* Antipsychotic medications
* Other medications that may affect fluid balance or weight

Lifestyle:

• Plans to move out of the study area within the next 4 months, or plan to be out of the study area for more than 3 weeks during the course of the study.
Evaluation of Resectability of Pancreatic Cancer Using Low kVp CT

The aim of this study is to investigate usefulness of low kVp high mAs computed tomography in evaluation of pancreatic cancer resectability.


Eligibility Criteria:
Inclusion Criteria:

* 1. age between 20 year-old and 85 year-old 2. patient with pancreatic cancer detected on standard CT scan using 120 kVp that obtained within one month 3. consider surgical resection for pancreatic cancer treatment 4. patients who can undergo contrast enhanced CT scan

Exclusion Criteria:

* 1. history of severe adverse reaction to iodine contrast 2. less than 60 of estimated GFR