cyrilzakka/clinical-trials huggingface dataset:
The Effects of Rhus Coriaria L. on Serum Uric Acid Levels

The aim of this study is to evaluate the effects of Rhus coriaria L. (Rhus) commonly known as "Somagh" on serum uric acid levels.

Rhus coriaria L.(Rhus) is a well-known spice widely consumed in the world which has also been utilized extensively for medicinal purposes. The antioxidant components of this plant made it a favorable target for laboratory and animal studies in different conditions such as oxidative stress cytotoxicity, diabetes and hyperlipidemia. Rhus (Somagh) is found in temperate and tropical regions worldwide, often growing in areas of marginal agricultural capacity. Rhus is used as an herbal remedy in traditional medicine because of its assumed analgesic, antidiarrheic, antiseptic, anorexic and antihyperglycemic properties. The fruits of Rhus contain flavonols, phenolic acids, hydrolysable tannins, anthocyans and organic acids such as malice, citric and tartaric acids. Some studies have shown that polyphenols could have beneficial effects on cardiovascular disease and cancer and could be regarded as bioactive compounds with a high potential health-promoting capacity. Phenolic compounds inhibit lipid peroxidation, scavenge the superoxide anion and hydroxyl radical, and enhance the activities of detoxifying enzymes.

Uric acid (UA; 7,9-dihydro-1H-purine-2,6,8(3H)-trione) has been implicated as a risk factor and cause of numerous disease states. Some disease states, such as gout, hypertension, and cardiovascular disease, have been shown to result when UA levels in the blood are too high. Hyperuricemia predicts the development of hypertension in the general population, and an independent positive correlation between UA levels and the occurrence of hypertension has been reported. Hyperuricemia may also be a risk factor for cardiovascular disease, myocardial infarction, and stroke.

The manipulation of serum UA levels has become a popular strategy in the treatment of a variety of diseases. This is either accomplished through dietary and lifestyle changes or through treatment with UA reducing drugs.

The aim of this study is to evaluate the effects of Rhus coriaria L. (Rhus) commonly known as Somagh on serum uric acid levels.

Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals

Exclusion Criteria:

* Serum uric acid levels that need medical treatment
* Gout
* Diabetes mellitus
* Hypo. or hyperthyroidism
* Any systemic illnesses e.g. liver cirrhosis, acute or chronic renal failure, heart failure
* Use of drugs: Uric acid lowering agents
* Pregnancy
* Lactation
* History of allergic reaction to Somagh
A Study for Participants With Advanced Cancer

This study is being conducted to determine the safety of LY2523355 for the treatment of advanced and/or metastatic cancer (including Non-Hodgkin's lymphoma).

This study is a multi-center, non-randomized, open label, dose-escalation, Phase 1 study of intravenous LY2523355 in participants with advanced and/or metastatic cancer (including Non-Hodgkin's Lymphoma) for whom no treatment of higher priority exists.

Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of advanced and/or metastatic cancer (solid tumors or Non-Hodgkin's lymphoma) that is refractory to standard therapy or for which no proven effective therapy exists. Participants entering Part B of the study must also have a tumor that is safely amenable to serial biopsies
* Have the presence of measurable or nonmeasurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST, Therasse et al. 2000) or Revised International Working Group Lymphoma Response Criteria (Cheson et al. 2007)
* Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
* Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, cancer-related hormonal therapy, or other investigational therapy for at least 28 days (6 weeks for mitomycin-C or nitrosoureas) prior to study enrollment
* Males and females with reproductive potential must agree to use medically approved contraceptive precautions during the trial and for 3 months following the last dose of study drug
* Females with child bearing potential must have had a negative urine or serum pregnancy test less than or equal to 7 days prior to the first dose of study drug
* Have an estimated life expectancy of greater than or equal to 12 weeks

Exclusion Criteria:

* Have symptomatic, untreated or uncontrolled central nervous system (CNS) metastases. Participants with treated CNS metastases are eligible provided their disease is radiographically stable, asymptomatic, and they are not currently receiving corticosteroids and/or anticonvulsants. Screening of asymptomatic participants without history of CNS metastases is not required
* Have current acute or chronic leukemia
* Have had an autologous or allogenic bone marrow transplant
* Have the following conduction abnormalities: PR \>250 milliseconds (msec), second degree or complete atrioventricular (AV) block, intraventricular conduction delay (IVCD) with QRS ≥120 msec, left branch bundle block (LBBB), right branch bundle block (RBBB), Wolf-Parkinson- White syndrome (WPW), left anterior fascicular block (LAFB), left posterior fascicular block (LPFB), or other conduction abnormality that in the opinion of the investigator would preclude safe participation in this study.
* Females who are pregnant or lactating
* Known hypersensitivity to pegfilgrastim or filgrastim
CANagliflozin Treatment And Trial Analysis-Sulfonylurea (CANTATA-SU) SGLT2 Add-on to Metformin Versus Glimepiride

The purpose of this study is to demonstrate the efficacy, safety, and tolerability of canagliflozin (JNJ-28431754) compared with glimepiride in patients with type 2 diabetes mellitus with inadequate control despite treatment with metformin.

Type 2 diabetes mellitus (T2DM) is well recognized as a major public health problem that presents patients with a significant risk of complications including heart disease, retinopathy, nephropathy, and neuropathy. Various classes of orally administered antihyperglycemic agents have been developed for the treatment of diabetes and although individual agents may be highly effective for some patients, it is still difficult to maintain optimal glycemic control in most patients, thereby resulting in high rates of morbidity and mortality in the diabetic population. This is a randomized, double-blind, active comparator-controlled, 3-arm, parallel-group, multicenter study to demonstrate the efficacy, safety, and tolerability of canagliflozin compared with a sulfonylurea (glimepiride) in patients with T2DM, 18 to 80 years of age, inclusive, who are not optimally controlled on metformin monotherapy. The primary study hypothesis is that the study drug will be non-inferior to glimepiride as assessed by the change in hemoglobin A1c (HbA1c) from baseline. The patients will receive capsules taken by mouth of canagliflozin (either 100 or 300 mg), or glimepiride with a starting dosage of 1 mg, which will be increased to a maximum dose of 6 or 8 mg once daily for a total duration of 104 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have a diagnosis of type 2 diabetes
* Body mass index (BMI) \>=22 to \<=45 kg/m2, at screening
* Patients must be taking a stable dosage of metformin as monotherapy at screening
* Patients must have a HbA1c between \>=7% and \<=9.5% at Week 2
* Patients must have a fasting plasma glucose (FPG) \<=270 mg/dL (15 mmol/L) at Week -2

Exclusion Criteria:

* Patients having prior exposure or known contraindication or suspected hypersensitivity to JNJ-28431754, glimepiride, or metformin
* History of diabetic ketoacidosis or type 1 diabetes mellitus
* History of pancreas or beta-cell transplantation
* History of active proliferative diabetic retinopathy
* History of hereditary glucose-galactose malabsorption or primary renal glucosuria
* Renal disease requiring treatment with immunosuppressive therapy within the past 12 months before screening or a history of dialysis or renal transplant
* Taken thiazolidinedione therapy in the past 16 weeks before screening
High Intensity Lipid Lowering Following Acute Coronary Syndromes for Persons Living With HIV

HILLCLIMBER is a randomized, controlled, open-label phase II trial of moderate dose statin therapy (pravastatin 40mg daily) versus high-dose statin therapy (rosuvastatin 20-40mg daily) in HIV-infected persons taking antiretroviral therapy (ART) who have coronary heart disease (CHD).

HILLCLIMBER is a randomized, controlled, open-label phase II trial of moderate dose statin therapy versus high-dose statin therapy in HIV-infected persons taking antiretroviral therapy (ART) who have coronary heart disease (CHD).

All subjects will have an initial 2-week run-in period with pravastatin 40mg daily (Week 0 to 2). Subjects not demonstrating significant toxicity at week 2 will then be randomized to rosuvastatin 20mg (high intensity dose group) versus continuing pravastatin 40mg daily (moderate intensity group) for 12 weeks (Weeks 2 to 14). At week 6, those in the rosuvastatin arm who do not demonstrate significant toxicity and whose LDL-c is \>60mg/dl and decreased by less than 25% compared with week 2 will then have doses increased to rosuvastatin 40mg.

Eligibility Criteria:
Inclusion Criteria:

* HIV-1 infection
* HIV RNA below the lower limit of assay detection within 12 months of study entry
* 1) Documented coronary heart disease (CHD): nonfatal MI, unrecognized MI, unstable angina pectoris, and/or stable angina pectoris, as defined by the American Heart Association Case Definitions for Acute Coronary Heart Disease in Epidemiology and Clinical Research Studies, OR Or (2) Documented 10-year ASCVD risk of 15% or greater based on the ACC/AHA ASCVD Risk Estimator
* Negative serum or urine pregnancy test
* Men and women age 18 to 75 years of age

Exclusion Criteria:

* Serious illness or AIDS-related complication within 21 days of screening requiring systemic treatment and/or hospitalization
* No coronary heart disease (CHD) and 10-year ASCVD risk \<15.0%.
* Not currently receiving antiretroviral therapy or taking any of the following antiretroviral agents: atazanavir/ritonavir, lopinavir/ritonavir.
* History of statin intolerance leading to discontinuation, dose decrease, or change to less potent dose equivalent
* Statin absolute contraindication
* Current use of atorvastatin 20mg daily or greater or rosuvastatin 10mg daily or greater
* Chronic kidney disease stage 4 or greater (including dialysis)
* Systolic heart failure with last documented LVEF \<35%
* Pregnant or breastfeeding
* Laboratory values obtained within 45 days prior to study entry:

LDL-c \<80 mg/dl while not on statin or LDL-c \<60 mg/dl while on statin ALT \> 3 x Upper Limit of Normal (ULN) AST \> 3 x ULN Creatinine kinase (CK) \>3 x ULN (calculated creatinine clearance (CrCl) \<50 mL/min, as estimated by the Cockcroft-Gault equation)

* Life expectancy \<12 months
* Prior organ transplant
* Active malignancy
* Inflammatory muscle disease
Bring Communities and Technology Together for Healthy Aging

Technology has been created to help older adults age well in their homes, but adoption and acceptance have been slow. The researchers are developing a low-cost web-based technology, called Elder Tree, for older adults and caregivers to address key challenges older adults face, such as loneliness and isolation, falls, loss of driving privileges, relapsing from proven falls prevention strategies, and unreliable home services. Elder Tree is being developed and tested with older adults and caregivers to identify, 1) usability issues such as font size, navigation and interface (audio, video,text) and 2) content and tailoring issues such as identifying local resources and events. This study will employ a randomized longitudinal design comparing a control group to an intervention group over a 12-month period. Investigators hypothesize that older adults using Elder Tree will experience greater independence and quality of life when compared to the control group. Investigators will use quantitative measures to determine how much our intervention improves: quality of life and health system use. These measures will help us to determine the cost effectiveness of Elder Tree. Investigators will recruit and test Elder Tree in 3 Regional Aging and Disability Resource Centers; one urban, one suburban and one rural setting, so to account for environmental and community differences. The older adult and their caregiver will be randomized to the same treatment group. Investigators will measure the effect over the 12 month intervention period and a 6 month follow-up period at 18 months.


Eligibility Criteria:
Inclusion Criteria:

* 65 years or older
* In need of IADL support
* 1 years history or risk of hospitalization or falls
* Resident of the following counties Milwaukee, WI, Waukesha Wi or Richland County
* Must be able to read English at a 6th grade level.

Exclusion Criteria:

* Under 65 years of age
* Unable to read English
* Not a resident of the above listed counties.
Laparoscopic Primary Diaphragm Versus Mesh Repair for Hiatus Hernia: a Long-Term Follow-Up

Assessment of the recurrence of hiatal hernia five to ten years after repair using sutures versus sutures reinforced with non-absorbable mesh.


Eligibility Criteria:
Inclusion Criteria:

* Participant of the initial PRIME study
* Alive

Exclusion Criteria:

* No informed consent
* Additional hiatal hernia repair surgery during the follow-up period
* Pregnancy
* Patients that have stated they do not want to be approached for follow-up research
Impact of an Echographic Algorithm on Hemodynamic Optimization in the First 4 Days of Septic Shock Management

Fluid management is one of the key issues in the initial management of septic shock (SS). Fluid overload and hypovolemia have been associated with increased mortality in several trials. Transthoracic echocardiography (TTE) and lung ultrasound are recommended for haemodynamic assessment in critically ill patients. However, the benefit of hemodynamic optimisation using echography has not been yet evaluated. The purpose of this multicenter, controlled, randomized trial is to assess the impact of an echocardiographic algorithm of hemodynamic optimization on fluid management in septic patients during the first 4 days of therapy.


Eligibility Criteria:
All eligible patients will have a cardiac echocardiogram prior to inclusion for the sole purpose of eliminating special situations that are part of the non-inclusion criteria listed below.

Inclusion Criteria

* Patient in an intensive care unit who develops septic shock on admission or during hospitalization, as defined by SEPSIS-3 criteria.
* Patient or trusted person / legal representative / family member / curator / guardian who has given free and informed consent and has signed the consent form or patient included in an emergency situation.
* Patient affiliated or beneficiary of a health insurance plan.
* Patient at least (≥) 18 years of age.

Exclusion Criteria:

* Refusal of consent.
* Patient under court protection or guardianship.
* Moribund patient with a life expectancy of less than 48 hours.
* Non-echogenic patient.
* Cardiac tamponade.
* Infective endocarditis.
* Intracavitary thrombus.
* Dilated cardiomyopathy with LVEF (Left Ventricular Ejection Fraction\<40%.
* Parturient or nursing patient.
Survey on Attitudes About COVID-19 Vaccinations in Italian HCW

The Project is aimed at analyzing the perceptions, knowledge, attitudes and intentions of the population towards the anti-SARS-CoV-2 vaccine in order to identify the determinants of vaccine refusal/hesitancy, and to guide specific activities aimed at updating and the implementation of institutional communication strategies on the vaccine, involving health professionals and targeting the general population.


Eligibility Criteria:
Inclusion Criteria:

* healthcare workers residing in Italy

Exclusion Criteria:

* healthcare workers not residing in Italy
Nerve Stimulation Using a TENS to Provide Pain Relief During Surgery for Overactive Bladder

This will be a double blind randomized control trial in men and women with urinary urge incontinence that are undergoing outpatient operative cystoscopy for Onabotulinumtoxin A chemo denervation as third line therapy for overactive bladder (OAB) or urinary urge incontinence (UUI). Subjects will be identified by the University of Rochester Urologists and Urogynecologists participating in the study who currently oversee urinary urge incontinence care. Subjects will be randomized into two groups. One group will be undergoing the cystoscopy with transcutaneous electrical nerve stimulation (TENS) for analgesia and the second group will have cystoscopy with placebo TENS.


Eligibility Criteria:
Inclusion Criteria:

* Men and Women, Age ≥18 years
* Diagnosis of OAB/UUI,
* Scheduled to undergo intravesical Botox injections in the office
* Able to read/write English

Exclusion criteria:

* Currently undergoing Sacral Neuromodulation
* Cutaneous damage such as ulcers or broken skin on target treatment area
* Currently implanted cardiac pacemaker or defibrillator
* Pre-procedural use of opioids for pain management, less than 8 hours from last dose
* Participants with altered sensation below the umbilicus
Randomized Cross-over TRD and CPAP for OSA

The objectives of this study is to compare short-term outcomes of CPAP and TRD in the treatment of obstructive sleep apnea. Study design is a randomized cross-over trial during 3-weeks period of each treatment in 36 patients. Primary outcomes are quality of life, degree of sleepiness, and severity of OSA determined by FOSQ ESS, and AHI or RDI, respectively.

The objectives of this study is to compare short-term outcomes of CPAP and TRD in the treatment of obstructive sleep apnea. Study design is a randomized cross-over trial during 3-weeks period of each treatment in 36 patients. Primary outcomes are quality of life, degree of sleepiness, and severity of OSA determined by FOSQ ESS, and AHI or RDI, respectively. Wash-in period 1 week and Wash-out periods 1 week are required before start each treatment.

Eligibility Criteria:
Inclusion Criteria:

1. OSA patients aged over 18 years old at Siriraj hospital
2. Apnea-hypopnea index (AHI) 5 - 30 events/ h or AHI \> 30 events/h but lowest Oxygen saturation \> 70%
3. Positive consented form

Exclusion Criteria:

1. Patients with severe periodontal diseases
2. Patients with unstable medical problems i.e. poorly controlled cardiovascular diseases, cancers, cerebrovascular diseases, epilepsy, dementia, etc.
3. total sleep time less than 2 hour during previous sleep study
4. Patients who could not tolerate the side effects of CPAP or TRD
5. Patients who could not follow-up until finishing the protocol or withdraw themselves from the study for any reasons.
Engaging Immigrants in Preventive Parenting Interventions

The objective of this community-based randomized controlled trial is to evaluate the outcomes of a theory-based parent engagement intervention (i.e., culturally-tailored video) aimed at promoting the participation of Filipino parents and grandparents in an evidence-based preventive parenting intervention.

Data will be obtained using pre and post surveys with self-report instruments and enrollment logs. It is hypothesized that 1) Parents and grandparents in the Intervention Arm will demonstrate greater behavioral outcomes (intention to enroll, actual enrollment, and participation in parenting intervention sessions) than those in the Control Arm. 2) Parents and grandparents in the Intervention Arm will show greater improvements from baseline in parent determinants (knowledge, beliefs, attitudes, benefits, and barriers) compared to the Control Arm. 3) Parents' intention to enroll, and actual enrollment in IY will be predicted by the study arm and parent determinants. This study is expected to have an important impact on the uptake of evidence-based parenting interventions among hard-to-reach populations and holds the promise of eliminating disparities in behavioral health outcomes in this understudied and growing minority population.

Eligibility Criteria:
Inclusion Criteria:

* The sample will consist of Filipino parents and grandparents of children/grandchildren between ages 6-12 years old. Inclusion criteria include:

  1. the parent or grandparent has at least one child between 6 to 12 years of age
  2. the participating parent/grandparent is Filipino
  3. At least one parent/grandparent is willing to complete pre and post surveys and watch a brief video
  4. the parent/grandparent is age 18 or older
  5. English fluency

Exclusion Criteria:

1. Younger than 18 years of age
2. Does not speak English
3. Target child has a developmental disability such as Trisomy 21 or autism
4. Parent or grandparent plans to move out of the area within the next nine months
Clinical Effectiveness of Damon Ultima Vs Conventional Brackets Trial)

Compare the clinical performance, root resorption and pain perception between passive self-ligating Damon Ultema vs conventional brackets.

Damon Ultima System was introduced and claimed to be the first true full expression orthodontic system designed for faster and more precise finishing. The brackets were completely reengineered to virtually eliminate play for precise control of rotation, angulation and torque. Moreover, the system used specially designed archwires regarding wire dimensions and shape to fulfill the manufacturers claim.

Eligibility Criteria:
Inclusion Criteria:

* 15-35 years of age patients who are healthy and without medications such as non-steroidal anti-inflammatory analgesics.
* Patients with Class I normal occlusion with moderate dental irregularity (with 4-6 irregularity index) requiring non-extraction treatment.
* Presence of all the permanent teeth apart from the third molars.
* Patients with good oral hygiene and periodontal health.
* Without previous orthodontic treatment/ functional appliances

Exclusion Criteria:

Patients will be excluded from recruitment if he had sever skeletal discrepancy that requires orthognathic surgery.

• Patients who have cleft lip or palate, hypodontia, or hyperdontia
Study to Determine the Effects of Co-Administration of Alcohol on the Absorption of Oxycodone From a Proprietary Controlled-Release Formulation

The study is designed to test whether or not the rate and extent of absorption of oxycodone from a proprietary controlled-release formulation is significantly affected by co-administration of alcohol compared with controlled conditions (when the formulation is administered with water). The primary pharmacokinetic parameters are the peak concentration of oxycodone (Cmax) and the overall exposure level of oxycodone as represented by the area under the plasma concentration-time curve (AUC).


Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers
* history of moderate alcohol consumption
* total body weight exceeding 64 kg

Exclusion Criteria:

* history of clinically significant disease
* history of sleep apnea
* any condition affecting drug absorption
* pregnant or nursing female subjects
* history of allergy or hypersensitivity to either oxycodone or naltrexone