cyrilzakka/clinical-trials huggingface dataset:
A Study to Assess the Efficacy, Safety, and Pharmacokinetics of ABP-671 in Patients With Gout or Hyperuricemia

This is a Phase 2a, multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the efficacy, safety, and pharmacokinetics study of 6 different dose regimens of ABP-671 compared with placebo. The study will consist of three sequential groups with escalating total daily ABP-671 doses. Each group is further divided into two dose cohorts with either QD or BID dosing. Each dose group will have 3 stages following screening: Run-in, Dose Evaluation, and Follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Subject is able to understand the study procedures, the risks involved and willing to provide written informed consent before the first study related activity.
* Subject meets the diagnosis of gout as per the American College of Rheumatism/ European League Against Rheumatism (EULAR) Gout Classification Criteria or diagnosis of hyperuricemia.
* Subject has an sUA level ≥ 7.0 mg/dL at baseline.
* Subject must be willing to discontinue any other UA-lowering medication (e.g., allopurinol, febuxostat, and probenecid) and take gout prophylaxis medication during the study.
* Body mass index (BMI) ≤ 40 kg/m2.

Exclusion Criteria:

* Subject with a documented history of rheumatoid arthritis or other autoimmune disease.
* Subject with any clinically significant hepatic, cardiovascular, renal, neoplastic, psychiatric illness, or hematological disorders such as polycythemia vera, sickle cell disease, or myelodysplastic disorder.
* Subject with a history of alcohol or drug abuse within the past 1 year prior to screening, or current evidence of substance dependence or abuse.
* Subject with a positive test for active hepatitis B, hepatitis C infection or human immunodeficiency virus (HIV) infection.
* Subject with active liver disease, or hepatic dysfunction.
* Subject with an inadequate renal function with estimated serum creatinine \> 1.5 mg/dL (\> 0.133 mmol/L) or creatinine clearance \< 60 mL/min (by Cockcroft-Gault formula).
* Subject with a history of malignancy within the previous 5 years with the exception of non-melanoma skin cancer that has been treated with no evidence of recurrence, treated cervical dysplasia or treated in situ Grade 1 cervical cancer.
* Subject with unstable angina, New York Heart Association class III or IV heart failure, myocardial infarction, stroke, or deep venous thrombosis within the last 12 months; or subjects currently receiving anticoagulants.
* Subject with QT interval corrected for heart rate according to Fridericia's formula \> 470 msec (females) and \> 450 msec (males) during the Screening Period, confirmed by a repeat assessment.
* Subject with uncontrolled hypertension
* Subject receiving chronic treatment with more than 325 mg aspirin per day.
* Subject that requires or may require systemic immunosuppressive or immunomodulatory treatment.
* Subject who received any investigational therapy within 30 days or 5 half-lives (whichever is longer) prior to screening.
* Subject who is pregnant or breastfeeding.
Comparison of Obturator Nerve Block With Ultrasound Guidance and Anatomical Signs

Comparison of the obturator nerve block in patients undergoing transurethral resection due to bladder tumor, technically using ultrasound guided or blinded with anatomical signs.

The primary aim of this study is to compare the success rates of ONB techniques performed with ultrasound guided or blind technique. Its secondary purpose is to compare the effect of peroperative bleeding and control cystoscopy performed in the postoperative 3rd month on the presence of recurrent tumor.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-II patients

Exclusion Criteria:

* Tumors that disrupt the integrity of the bladder,
* bladder floor tumors,
* coagulation disorders,
* motor in the lower limbs
* with sensory disturbances,
* uncooperative patients,
* Known allergy to local anesthetics
* patients with localized infection at the procedure site
Remembered Meal Satisfaction, Satiety and Later Snack Food Intake

This study examined whether remembered meal satisfaction (encompassing memory for meal liking and satiety) can be manipulated in the laboratory and whether this influences later food intake.

This study examined whether remembered meal satisfaction (encompassing memory for meal liking and satiety) can be manipulated in the laboratory and whether this influences later food intake. In a between-subjects design participants consumed a fixed lunch and then rehearsed the satisfying or dissatisfying aspects of the meal, or a neutral experience (control), in order to manipulate memory for meal satisfaction. Three hours later, in a second visit to the laboratory, participants completed a bogus taste-test to measure food intake and meal memory measures.

Eligibility Criteria:
Inclusion Criteria:

* Fluent English
* Not taking medication that affects appetite
* No known history of food allergies or disordered eating
Prevention of Invasive Fungal Infections (IFIs) in Subjects Receiving Chemotherapy for Acute Lymphoblastic Leukemia

The study aims to investigate whether prophylaxis with liposomal amphotericin B (AmBisome®) can reduce the incidence of invasive fungal infections (IFIs) in patients with Acute Lymphoblastic Leukemia (ALL) who are undergoing their first remission induction.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed ALL receiving an ALL chemotherapy regimen that typically induces at least 10 days of neutropenia defined as an absolute neutrophil count \< 500 cells/mm\^3 or 0.5 × 10\^9 cells/L

  * Subjects with lymphoblastic lymphoma or any malignancy other than ALL are NOT eligible for this study.
* Age ≥ 18 years
* Able to have all screening tests performed quickly to ensure results can be obtained and evaluated before randomization so that the first dose of randomized study drug for IFI prophylaxis can be administered within 5 days of first remission-induction chemotherapy

  * Preremission induction treatment (ie, pre-phase) with a minimally or nonmyelosuppressive regimen for up to one week is not considered to constitute the beginning of remission induction chemotherapy
* Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures

Exclusion Criteria:

* Known hypersensitivity to amphotericin B or AmBisome, the metabolites or formulation excipients, in particular known history of anaphylactic reaction to amphotericin B or AmBisome or any of its metabolites or formulation excipients
* Known hypersensitivity to the excipients of the placebo formulation
* Current fever (≥ 38°C) unless explained by noninfectious causes
* Subjects with proven, probable or possible IFI (according to European Organization for the Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG) criteria) at screening or in subject history
* Pulmonary infiltrates
* Concomitant or previous treatment with an antifungal drug within the previous 30 days unless the plasma level is below the limit of detection or at least 5 half-lives of the antifungal has elapsed since the treatment was given
* Serum creatinine \> 2 × the upper limit of the normal range (ULN)
* Grade 3 Liver function test results: alanine aminotransferase or aspartate aminotransferase \> 5 × ULN; total bilirubin \> 2.5 x ULN
* Any severe co morbidity other than underlying hematological disease (ALL), which in the investigator's judgment may interfere with study evaluations or affect the subject's safety
* Subjects who have taken any investigational drug in the last 30 days prior to screening, with the exception of ALL chemotherapy investigational products being used as part of the subject's current ALL treatment protocol
* Pregnant or nursing females
* Subjects with a prior history of a malignancy that was treated with a myeloablative chemotherapy regimen are NOT eligible for this study.
Efficacy Study of Standard Ballroom and Latin Dance Program in Type 2 Diabetes and Obesity

to test the metabolic and clinical effects of a 6-month program of dancing in subjects with type 2 diabetes and/or obesity, chronically cared for in two diabetes/metabolic units. Self-selection of the leisure time activity program was allowed to increase adherence to the physical activity programs.


Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes in fairly good metabolic control (glycosylated hemoglobin (HbA1c) \< 8.5%) and/or obesity (Body Mass Index (BMI) ≥ 30 kg/m2 or waist circumference \>94 cm in males, \>80 in females), with/without prediabetes or minor alterations of HbA1c.

Exclusion Criteria:

* previous cardiovascular events, muscle-skeletal problems reducing physical ability, any general condition limiting systematic adherence
Effect of Platelet Inhibition and / or Lipid Lowering in Non-ACS-patients With Positive Troponin

The study evaluates the effect of platelet inhibition and / or lipid lowering in non-ACS-patients with symptoms suggestive for ACS, and elevated high-sensitivity troponin values

Current databases show, that high-/ ultra sensitive (hs)/ (us) troponin levels above the 99th percentile in patients presenting with chest pain are indicative for future cardiovascular events, even when acute coronary syndrome (ACS) was ruled out. Most of these non-ACS-patients are discharged without specific/ preventive therapy (anti-platelet or anti-lipid), although "positive" troponin values (any value at any time during hospitalisation above the 99th percentile) seem to clearly indicate underlying myocardial ischemia. In summary, there is an unmet need and huge potential to reduce mortality and morbidity in Chest Pain Unit patients by specific therapy. The investigators propose that platelet inhibition by Aspirin or lipid lowering by Atorvastatin will prevent plaque rupture and superimposition of thrombosis to coronary atherosclerosis in this population. It is planned to conduct a controlled clinical trial: 3,000 troponin positive patients presenting at emergency room (ER)/ CPU with symptoms suggestive for ACS, but an ACS was ruled out, will be assigned randomly to Aspirin 100 mg and/ or Atorvastatin 20 mg versus placebo (2x2 factorial design).

Eligibility Criteria:
Inclusion Criteria:

* Patient with symptoms suggestive for ACS presenting within 48 hours after onset in the ER/ Chest Pain Unit (CPU)
* Patient has at least one elevated high-sensitivity troponin I or T value
* Chest pain is classified as non-ACS, despite elevated hsTn (e.g. because of missing troponin dynamics)
* At least 50 years of age

Exclusion Criteria:

* Indication for antiplatelet therapy (e.g transient ischemic attack, or stable coronary artery diseases -CAD) or anticoagulation therapy (such as atrial fibrillation)
* Indication for anti-lipid therapy
* Any evidence of an acute myocardial necrosis (e.g imaging evidence of new regional wall motion abnormality, or significant ST-segment-T wave (ST-T) changes in ECG)
* Untreated clinically significant CAD requiring revascularization
* Hemoglobin value below 8 mg/d, and/or creatinine kinase ≥3 times ULN, and/or AST or ALT ≥3 times ULN
* Active malignancy of any organ system, treated or untreated. Subjects have to be in remission for at least 36 months to be eligible.
Assessment of Left Atrial Appendage Morphology in Patients After Ischemic Stroke

Stroke remains the most dangerous and frightening complication of atrial fibrillation (AF). Numerous factors predisposing to peripheral embolism in patients with AF have been well defined, documented and included in the CHA2DS2VASC score. Although proper anticoagulation minimizes the risk attributable to "known" risk factors, stroke may still occur. Thus, "unknown" risk factors may play an important role in stroke risk stratification in patients with AF. The investigators assume that one of the important "unknown" risk factor is left atrial appendage (LAA) morphology. The ASSAM study is planned to include 100 patients after ischemic stroke or transient ischemic attack (TIA) and known status of anticoagulation at the time of stroke. The control group will consist of 100 patients scheduled for AF ablation without a history of stroke or TIA.


Eligibility Criteria:
Inclusion Criteria:

* history of ischemic stroke or transient ischemic attack
* history of AF/AL
* known status of anticoagulation at the time of stroke (treatment dose, INR level)

Exclusion Criteria:

* hemorrhagic stroke
* serious renal impairment with GFR \<30 ml/min
* hyperthyroidism
* allergy to the contrast agent
* mental inability to sign the informed consent
* receptive aphasia
Relative Bioavailability Study of Lipidil® Supra (Fenofibrate 160mg) Versus SYO-0805 (Fenofibrate 65mg)

The purpose of this study is to evaluate the bioequivalence of Lipidil® Supra (fenofibrate 160mg) versus SYO-0805 (fenofibrate 65mg) in single dose oral administration.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults 20-50 years of age
* Weight more than 55kg and within ±20% IBW(Ideal Body Weight)
* Voluntary written informed consent

Exclusion Criteria:

* History or presence of significant renal, neurologic, pulmonary, endocrine, hematology, oncology, urologic, cardiovascular, musculoskeletal or psychiatric disease
* Drug allergies to fenofibrate
* Recent history or evidence of drug abuse
* Recent participation(within 2months) in other clinical studies
* Recent donation of blood(within 2months) or plasma(within 1months)
Randomized Study on Endometrioma Treatment

This is a randomised study comparing the effect of two laparoscopic techniques for treatment of ovarian endometriomas on recurrence rate and ovarian reserve.


Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 40 years
* uni or bilateral symptomatic endometriotic cysts with a minimum diameter of 30 millimetres
* no counter-indication for the use of GnRH analogues

Exclusion Criteria:

* previous pelvic surgeries
* history of cancer
* suspected malignancy
* presurgical suspicion or evidence of deep endometriosis
* presurgical suspicion or evidence of premature ovarian failure
* use of oestrogen suppressive drugs in the preceding 6 months
General Population Level Estimation for Type 1 Diabetes Risk in Children During Routine Care Delivery

In partnership with Helmsley Charitable Trust, the Sanford PLEDGE Study is a large-scale, observational, feasibility study of general population screening for T1D and celiac autoantibodies. Screening is incorporated into routine health care visits within an integrated health system.

Most children with type 1 diabetes (T1D) do not have a family member with diabetes and often are not diagnosed until the child is very sick. Research suggests that screening and identifying children at risk for T1D autoantibodies can prevent serious illness at the time of diagnosis and improve long-term health outcomes.

The investigators will screen children, ages 0-5.99 or 9-16 years for blood markers related to T1D and celiac disease during routine healthcare delivery at birth, 1, 2 and 5 years, or once between 9 and 16 years of age. Children with confirmed autoantibodies will be offered participation in other monitoring or prevention trials (T1D), or referred to clinical care (celiac).

Eligibility Criteria:
Inclusion Criteria:

* Newborn Entry: Viable, term infants, defined as 36 weeks gestation by either dates or ultrasound who are born to pregnant women, 18 years or older, who are willing and able to provide informed consent (IC) prior to the onset of active labor. Who are born at a Sanford Health Hospital and plan to have routine well-child care at a Sanford Clinic
* Pediatric Entry: Children less than 6 years of age who receive their routine care at a Sanford facility and whose parents are able to provide IC.
* Adolescent Entry: Children, ages 9-16 years old, who receive their routine care at a Sanford facility and whose parents are able to provide IC.
* Siblings of children known to have T1D-relevant antibodies; ages 6 to 17 years old who receive care at a Sanford clinic
* Have an active MyChart account (with proxy access).

Exclusion Criteria:

* Subject is in the opinion of the investigator, unable to comply with the requirements of the study protocol.
* Children known to have T1D
Environmental and Reproductive Health Risk for Lewy Body Dementia

The goal of this survey study is to identify environmental, occupational and reproductive health risk factors for Lewy body dementia, which includes Parkinson's disease dementia and dementia with Lewy bodies. Participants will complete a one-time survey online or over the phone that includes questions on environmental, occupational factors they may have been exposed to and on medical history including reproductive health. Researchers will then compare the responses of people with Lewy body dementia and people without Parkinson's or memory/thinking problems to see which factors play a role in Lewy body dementia. Identifying risk factors can guide future treatment efforts and provide more insight to this dementia.

Lewy body dementia, including Parkinson's disease dementia and dementia with Lewy bodies, is one of the most common dementias and does not have a cure for now. It can occur differently for women and men, although we are not sure why. The ratio of women to men for the disease prevalence changes with older age, suggesting a potential role for reproductive factors, particularly for women. Environmental factors impact the risk for other types of dementia, although such factors have not been clearly described in Lewy body dementia specifically. Women and men may get exposed to different environmental and occupational risk factors, and the impact of factors can differ for women and men. By using one-time survey that can be completed online or over the phone, we will try to understand which environmental, occupational or reproductive health factors play a role in Lewy body dementia for women and men. By comparing the survey responses of people with Lewy body dementia and people without Parkinson's or memory/thinking problems, we aim to identify specific risk factors for women and men that can guide future treatment efforts and provide more insight into this dementia.

Eligibility Criteria:
Inclusion Criteria:

* For participants with Lewy body dementia: Clinical diagnosis of Lewy body dementia (Parkinson's disease dementia or dementia with Lewy bodies)
* For controls: Normal cognition
* Implication of consent to participate by stating consent verbally over the phone or by selecting the appropriate response on the online survey to indicate consent

Exclusion Criteria:

* For controls: Parkinson's disease or dementia diagnosis
Efficacy Optimizing Research of Chronic Hepatitis B Patients With Inadequate Response to NUC Therapy

The purpose of this study is to evaluate the efficacy and safety of generic entecavir monotherapy or in combination with adefovir for chronic hepatitis B patients with inadequate response to NUC therapy


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18-65 years;
* Capable of understanding and signing the informed consent. Willing to comply with the study requirements;
* Serum HBsAg positive and ALT\<10ULN at study screening;
* Patients have been treated with one nucleoside/nucleotide analogue for more than 6 months and are still on treatment;

Exclusion Criteria:

* History of viral breakthrough or genotypic resistance on previous therapy;
* History of decompensated liver function, or current signs/symptoms of decompensation e.g. ascites, variceal bleeding, encephalopathy or spontaneous peritonitis;
* Patient has a history of hepatocellular carcinoma(HCC) or findings suggestive of possible HCC;
* Other protocol defined exclusion criteria.
A Placebo-controlled Trial of Chronic Total Occlusion Percutaneous Coronary Intervention for the Relief of Stable Angina

ORBITA-CTO Pilot is a double blinded randomised placebo-controlled trial comparing the effects of chronic total occlusion percutaneous coronary intervention versus placebo on symptoms of angina in patients with background optimal medical therapy.


Eligibility Criteria:
Inclusion Criteria:

ORBITA CTO will enrol patients who meet all 5 of the following criteria:

1. Accepted for CTO PCI procedure by a specialist CTO operator.
2. Patients with symptoms related to a single vessel CTO (≥3 months duration, or probable CTO where duration is unknown) in a vessel of at least 2.5mm diameter without angiographically significant (LMS ≥50%, LAD/Cx/RCA/Graft ≥70%, ≥2mm diameter) coronary artery stenosis in remaining non-CTO vessels.

   Symptoms are:

   a) Typical exertional angina defined as: i) constricting discomfort in the front of the chest or in the neck, jaw, shoulder or arm ii) precipitated by physical exertion iii) relieved by rest or nitrates within 5 minutes b) Angina symptoms at rest (including decubitus angina and post-prandial angina).

   c) Shortness of breath on exertion considered to be angina equivalent.
3. Clinical evidence of ischaemia in CTO territory on dobutamine stress echocardiography, nuclear myocardial perfusion scan, stress perfusion CMR or PET).
4. Evidence of viability: If left ventricular angiogram or echocardiogram demonstrates LV impairment or RWMA then viability must be demonstrated.
5. J-CTO score ≤ 3.

Exclusion Criteria:

1. Acute coronary syndrome within 4 weeks.
2. PCI to non-CTO lesion in prior 4 weeks as part of ACS or elective PCI.
3. Non-revascularised clinically important non-CTO vessel.
4. Proven ischaemia (invasive or non-invasive) in non-culprit territory.
5. Contraindications to PCI or drug-eluting stent (DES) implantation.
6. Inability to tolerate or contraindication to DAPT.
7. Severe valvular heart disease.
8. Severe chronic pulmonary disease (FEV1 \<30% of predicted value).
9. Severe musculoskeletal disease resulting in immobility.
10. Life expectancy \<2years.
11. Pregnancy.
12. Age \<18years.
13. Inability to consent.