cyrilzakka/clinical-trials huggingface dataset:
Phase IIa Study of ALLN-346 (Engineered Urate Oxidase) in Subjects With Hyperuricemia, Gout and Chronic Kidney Disease

The purpose of this Phase IIa study is to evaluate the safety, tolerability and pharmacodynamics of ALLN-346 in subjects with hyperuricemia and gout, and with mild to moderate chronic kidney disease.

This is a randomized, double-blind, placebo-controlled parallel group, multi-center phase II clinical study or orally administered ALLN-346 in subjects with hyperuricemia, gout and mild to moderate chronic kidney disease over a two-week period. Subjects will be enrolled in two cohorts based on estimated glomerular filtration rate (eGFR).

Eligibility Criteria:
Inclusion Criteria:

* Male or female, age 18 to 70 years
* Serum UA level ≥ 8.0 mg/dL at Screening (hyperuricemia)
* Meets 2015 American College of Rheumatology (ACR)/EULAR criteria for gout
* Screening eGFR of ≥60 - \<90 mL/minute/1.73 m2 for Cohort A and ≥30 - \<60 mL/minute/1.73 m2 for Cohort B.
* Concomitant medications stable for a minimum of 4 weeks prior to and during Screening
* Body Mass Index (BMI) ≥ 18 and ≤ 40 kg/m2, inclusive, at screening
* Not pregnant, not capable of pregnancy, not nursing, and agrees to use an effective method of contraception; males subjects must agree to abstain from sperm donation

Exclusion Criteria:

* Currently taking any oral urate-lowering medication within 2 weeks prior to Screening
* Prior uricase therapy or exposure to recombinant uricase, such as Rasburicase or Pegloticase
* Gout flare requiring treatment within 14 days prior to or during Screening
* Clinically significant finding during Screening, any ongoing clinically significant illness requiring a clinically significant intervention or change in management within 4 weeks prior to or during Screening
* History of GI surgery, including gastric sleeve, Roux-en-Y or gastric banding (unless gastric band removed for a minimum of 12 months prior to Screening
* Received treatment with or exposure to an Investigational drug or device within 30 days - prior to or during Screening
* Prior dosing in ALLN-346 clinical study
* Per Investigator judgment, is not an ideal clinical study candidate
Lenvatinib, Sintilimab, and DEB-TACE With/Without HAIC for HCC >7 cm With PVTT

This study is conducted to evaluate the efficacy and safety of lenvatinib plus sintilimab, transarterial chemoembolization (TACE) with drug-eluting beads (DEB-TACE) and hepatic artery infusion chemotherapy (HAIC) with FOLFOX regemen (LEN+SIN+DEB-TACE+HAIC) versus lenvatinib plus sintilimab and DEB-TACE (LEN+SIN+DEB-TACE) for large hepatocellular carcinoma (\> 7cm) with portal vein tumor thrombosis (PVTT).

This is a multicenter, prospective and randomized study to evaluate the efficacy and safety of LEN+SIN+DEB-TACE+HAIC compared with LEN+SIN+DEB-TACE for unresectable large HCC (\>7cm) with PVTT.

320 patients with large HCC (\> 7cm) and PVTT will be enrolled in this study. The patients will receive either Len+DEB-TACE+HAIC or Len+DEB-TACE using an 1:1 randomization scheme. In the LEN+SIN+DEB-TACE+HAIC arm, the microcatheter will be reserved at the main hepatic tumor-feeding artery after DEB-TACE and chemotherapy drugs (oxaliplatin, fluorouracil and leucovorin; FOLFOX-based regimen) will be intra-arterially administered though the microcatheter. DEB-TACE+HAIC treatments can be repeated based on the evaluation of follow-up laboratory and imaging examination by the multidisciplinary team. In the LEN+SIN+DEB-TACE arm, patients will be treated with DEB-TACE alone. TACE treatment can be repeated based on the evaluation of follow-up laboratory and imaging examination by the multidisciplinary team. In both arms, lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight \<60kg) P.O. qd and sintilimab 200mg I.V. q3w will be started within 7 days after the first DEB-TACE+HAIC/DEB-TACE.

The primary end point of this study is time to progression (TTP). The secondary endpoints are tumor response (objective response rate and disease control rate), overall survival (OS), and adverse events (AEs).

Eligibility Criteria:
Inclusion Criteria:

* a confirmed diagnosis of HCC
* the largest intrahepatic lesion \>7 cm
* presence of PVTT on imaging
* tumor recurrence after curative treatment (hepatectomy or ablation) is eligible for enrollment
* Eastern Cooperative Oncology Group performance status ≤1
* Child-Pugh class A/B
* adequate hematologic and organ function, with leukocyte count\>3.0×10\^9/L, neutrophil count\>1.5×10\^9/L, platelet count≥75×10\^9/L, hemoglobin 85 g/L, alanine transaminase and aspartate transaminase≤5×upper limit of the normal, creatinine clearance rate≤1.5×upper limit of the normal; prothrombin time prolongation ≤4 seconds
* life expectancy of at least 3 months

Exclusion Criteria:

* accompanied with vena cava tumor thrombus
* central nervous system involvement
* previous treatment with TACE, HAIC, TAE, radiotherapy, or systemic therapy
* organ (heart and kidneys) dysfunction, unable to tolerate TACE or HAIC treatment
* history of other malignancies
* uncontrollable infection
* history of HIV
* history of organ or cells transplantation
Dry Needling and Therapeutic Exercise on Sleep in Individuals With Chronic Neck Pain and Sleep Disturbance

Feasibility study investigating the effects of dry needling on individuals with chronic neck pain and sleep disturbance.

The purpose of this pilot study is to determine the feasibility of a large randomized clinical trial (RCT) which aims to investigate the effects of dry needling (DN) in addition to therapeutic exercise (TE) on sleep duration and quality in patients with chronic neck pain (CNP) and sleep disturbance (SD). Specifically, the objective is to explore feasibility of a study protocol and examine the preliminary data of a small sample size for the effectiveness of DN and TE for individuals with CNP and SD to determine effect size of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Neck pain lasting greater than 3 months 28,29
* Age: 18-75 years
* Presence of sleep disturbance - to be defined as a score ≥ 8 on the Insomnia Severity Index
* Ability to understand study procedures and to comply with them for the entire length of the study

Exclusion Criteria:

* Previous surgery to the neck or thoracic spine
* Central nervous system disorders
* Systemic joint disease (e.g. rheumatoid arthritis)
* Infection
* Cancer
* Raynaud's disease
* Pregnancy
* Immunocompromised disease (e.g., diabetes mellitus, HIV, AIDS, lupus)
* Insufficient English-language skills to complete all questionnaires.
* Contraindications to dry needling:

  * Presence of needle phobia
  * History of abnormal reaction to needling or injection
  * History of bleeding disorder (e.g., current anticoagulant therapy or known thrombocytopenia)
1-year Study to Assess the Efficacy, Safety, and Tolerability of Glycopyrronium Bromide (NVA237) in Chronic Obstructive Pulmonary Disease (COPD)

This study was designed to investigate the 1 year efficacy and safety of the 50 µg once daily (od) dose of glycopyrronium bromide (NVA237) in patients with moderate to severe chronic obstructive pulmonary disease.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female adults aged ≥ 40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure.
2. Patients with moderate to severe stable chronic obstructive pulmonary disease (COPD, Stage II or Stage III) according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines 2008.
3. Current or ex-smokers who have a smoking history of at least 10 pack years.
4. Patients with a post-bronchodilator forced expiratory volume in 1 second (FEV1) ≥ 30% and \< 80% of the predicted normal, and post-bronchodilator FEV1/forced vital capacity (FVC) \< 0.7 at Visit 2 (Day -14).
5. Patients, according to daily electronic diary data between Visit 2 (Day -14) and Visit 3 (Day 1), with a total score of 1 or more on at least 4 of the last 7 days prior to Visit 3 (Day 1).

Exclusion Criteria:

1. Pregnant women or nursing mothers (pregnancy confirmed by positive urine pregnancy test).
2. Women of child-bearing potential, unless using an approved method of medical or surgical contraception.
3. Patients requiring long term oxygen therapy (\> 15 h a day) on a daily basis for chronic hypoxemia, or who have been hospitalized for an exacerbation of their airways disease in the 6 weeks prior to Visit 1 (Day -21) or between Visit 1 (Day -21) and Visit 3 (Day 1).
4. Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1 (Day -21).
5. Patients who, in the judgment of the investigator or the responsible Novartis personnel, have a clinically relevant laboratory abnormality or a clinically significant condition.
6. Patients with any history of asthma indicated by (but not limited to) a blood eosinophil count \> 600/mm\^3 (at Visit 1, Day -21) and onset of symptoms prior to age 40 years.
7. Patients with a history of long QT syndrome or whose QTc measured at Visit 1 (Day -21) (Fridericia method) is prolonged (\> 450 ms for males or \> 470 ms for females.

Other protocol-defined inclusion/exclusion criteria may apply to the study.
Study to Examine the Effect of HKI-272 on Rhythms of the Heart (Cardiac Repolarization)

The purpose of this study is to determine whether HKI-272 affects the rhythms of the heart (cardiac repolarization).


Eligibility Criteria:
Inclusion Criteria:

* Men or women of nonchildbearing potential,
* 18-50 years old.
* Healthy as determined by the investigator, including physical examination, laboratory test results, and medical history.
GENERAL;GENeral Practitioners and Embolism pRevention in NVAF Patients Treated With RivAroxaban:reaL-life Evidence

In atrial fibrillation patients,anticoagulant therapy with warfarin has an excellent stroke preventive. Meantime,Warfarin may also increase the risk of hemorrhagic events. Considering this,warfarin is a drug which puts a great burden on patients and medical providers.

With the population aging, the number of non-valvular atrial fibrillation patients is increasing, and a necessity that not only specialist but also general practitioners. Anticoagulant therapy with warfarin is not easy for general practitioners and is not commonly used among general practioners. In such circumstances, Rivaroxaban,a new oral direct factor Xa inhibitor,has become available. Rivaroxaban is administrated once a day and exert an anti- coagulant effect soon after administration. It hardly reacts with foods or other drugs and therefore does not require regular monitoring. GENERAL study is to investigate the effectiveness of stroke and systemic embolism in non-valvular atrial fibrillation patients when it is prescribed by general practioners in real life settings.


Eligibility Criteria:
Inclusion Criteria:

* Non-valvular atrial fibrillation patient who are prescribed Rivaroxaban by General practitioners

Exclusion Criteria:

* Patients are contraindicated for rivaroxaban
* Patients judged as inappropriate for this study by investigators
Surgical Mesh in Radical Cystectomy to Prevent Parastomal Hernias

Radical cystectomy with ileal conduit urinary diversion serves as a foundational curative treatment strategy for selected patients afflicted with urothelial carcinoma of the bladder. Parastomal hernia after this procedure is an underestimated and undertreated clinical entity, which heavily impairs patients' quality of life due to symptoms of pain, leakage, application or skin problems. There is little evidence about prophylactic mesh placement for parastomal hernia prevention. In this study we examine the use of meshes during radical cystectomy and compare them with a control group.

Radical cystectomy with ileal conduit diversion is a procedure possible with complications. A primary stoma-related complication is the parastomal hernia (PH), which presents significant challenges to both the medical community and the patient. PH is classically defined as the protrusion of abdominal contents via the abdominal wall, especially in the direct vicinity of a stoma, whether it be a colostomy, ileostomy, or ileal conduit stoma. The incidence of PH post ileal conduit urinary diversion is especially concerning, with reports estimating its occurrence at around 17%. This data only emphasizes the need to reevaluate and optimize surgical treatments for PH, particularly as, in many cases, management strategies are extrapolated from experiences with colostomies or ileostomies. Notably, PHs are often described after these procedures rather than RC with ileal conduit urinary diversion. Further complicating the issue is the fact that estimates suggest around 30% of patients develop a PH within 12 months post any type of stoma site surgery. For those undergoing ileal conduit urinary diversion specifically, recurrence rates following PH repair can be alarmingly high, with figures as steep as 69% within a year.

Eligibility Criteria:
Inclusion Criteria:

* muscle-invasive or high-risk non-muscle-invasive bladder cancer patients

Exclusion Criteria:

* different than surgical therapy
Relevance of the Ethanol Dose in the Generation of Endogenous Hydroxytyrosol

Health benefits for humans derived from low dose intake of ethanol could partially be explained by its interaction with dopamine (DA) oxidative metabolism. Ethanol is expected to induce an increase in the formation of a DA minor metabolite: DOPET (hydroxytyrosol). Hydroxytyrosol is one of the most potent antioxidants present in Mediterranean Diet. The study is aimed at establishing the contribution of ethanol on hydroxytyrosol formation.


Eligibility Criteria:
Inclusion Criteria:

* Clinical history and physical examination demonstrating no organic or psychiatric disorders.
* The ECG and general blood and urine laboratory tests performed before the study should be within normal ranges. Minor or occasional changes from normal ranges are accepted if, in the investigator's opinion, considering the current state of the art, they are not clinically significant, are not life-threatening for the subjects and do not interfere with the product assessment. These changes and their non-relevance will be justified in writing specifically.
* The body mass index (BMI=weigh/height2) will range from 19 to 27 kg/m2, and the weight from 50 to 110 kg.
* Understanding and accepting the study procedures and signing the informed consent.

Exclusion Criteria:

* Not meeting the inclusion criteria.
* History or clinical evidence of alcoholism, drug abuse, or regular use of psychoactive drugs.
* Having suffered any organic disease or major surgery in the three months prior to the study start.
* History of psychiatric disorders.
* Smokers of more than 20 cigarettes per day.
* Taking more than 30 g of alcohol a day
* Regular use of any drug in the month prior to the study sessions.The treatment with single or limited doses of symptomatic medicinal products in the week prior to the study sessions will not be a reason for exclusion if it is calculated that it has been cleared completely the day of the experimental session.
* Blood donation 8 weeks before or participation in other clinical trials with drugs in the previous 12 weeks.
* Subjects with intolerance or adverse reactions to ethanol
* History or clinical evidence of gastrointestinal, liver, renal or other disorders which may lead to suspecting a disorder in drug absorption, distribution, metabolism or excretion, or that suggest gastrointestinal irritation due to drugs.
* Subjects unable to understand the nature, consequences of the study and the procedures requested to be followed.
* Subjects with positive serology to Hepatitis B, C or HIV.

To be eligible, the subjects must agree to follow a diet free from ethanol and olive oil in the 72 hours prior to the start of each session and until the end of the study.
Global® AP™ Total Shoulder Arthroplasty

This study will evaluate the clinical performance of DePuy Global® AP™ Shoulder prosthesis using the anchor pegged glenoid component and clinical and radiographic evaluations.

The purpose of the study is to determine the difference between pre-operative and post-operative levels of patient satisfaction, shoulder function, radiographic alignment, shoulder pain and patient satisfaction in patients receiving a Global® AP™ shoulder prosthesis for glenohumeral arthritis.

Eligibility Criteria:
Inclusion Criteria:

* Patients selected for inclusion will present for primary shoulder arthroplasty with a diagnosis of osteoarthritis and will consent to participate.

Exclusion Criteria:

* Are under 18 years of age or over 70
* Diagnosis of AVN, Inflammatory Arthritis, Fracture or Malunion.
* Have a hemi-arthroplasty
* Have destruction of the proximal humerus that precludes rigid fixation of the humeral component
* Have arthritis with insufficient cuff tissue
* Have had a failed rotator cuff surgery
* Have loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified
* Have evidence of active infection
* Present with a condition of neuromuscular compromise of the shoulder (e.g., neuropathic joints or brachial plexus injury with a flail shoulder joint) - Have a known active metastatic or neoplastic disease
* Are unwilling or unable to comply with a rehabilitation program or would fail to return for the postoperative follow-up visits prescribed by the protocol
* Are skeletally immature.
* Have a known allergic reaction to implant metals, polyethylene or a tissue reaction to corrosion or wear products
* Have other conditions such as central nervous system disturbances, alcohol or drug addiction, etc. that may make effective evaluation of the joint replacement difficult or impossible
* Are currently participating in another clinical study
* Are taking \> 10mg/day corticosteroids (e.g. prednisone) excluding inhalers, within 3 months prior to surgery
* Are currently involved in any personal injury litigation, medical legal or worker's compensation claims.
The Effects of Standardized vs Individualized Seat Height on 1-minute Sit-to-stand Performance

The 1-minute sit-to-stand test (1MSTS) is a widely used functional capacity test and has promising predictive potential. Current standards of practice suggest the use of a chair with a standardized height. However, this practice makes the test more demanding for taller individuals than for shorter individuals. This implies over- or underestimation of functional capacity depending on body morphology.

Therefore, the aim of this study is to investigate the influence of knee joint angle, femur length and bodyweight on the 1MSTS performance in healthy subjects with different morphology.

This is a randomized cross-over trial with the participants performing both procedures twice in one visit. Sufficient breaks in between the tests is granted.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent as documented by signature
* Age 18 and older
* Healthy
* Ability to conduct a 1-minute sit-to-stand-test
* Ability to follow study procedures and instructions in German

Exclusion Criteria:

* Known cardiopulmonary or metabolic diseases (e.g., heart disease, diabetes mellitus etc.)
* Smoking (ex-smoker allowed; if they stopped smoking at least one year before the study inclusion)
* Physical or intellectual impairment precluding informed consent or protocol adherence
* Respiratory infection in the last two weeks
* Pain during sit-to-stand movement
Improving Detection and Evidence-based Care of NAFLD in Latinx and Black Patients With Type 2 Diabetes

The primary objective of this pilot study is to assess the feasibility and acceptability of an intervention for improved detection and evidence-based care of NAFLD in Latinx and Black patients with type 2 diabetes (T2D) in Duke University Healthcare system (DUHS). We will enroll 10-15 Latinx and 10-15 Black patients with T2D and NAFLD, based on having mildly elevated liver enzymes (ALT \>/= 40 IU/mL in males, ALT \>/= 31 IU/mL in females) and exclusion of other liver diseases (e.g., viral hepatitis, alcohol abuse).

Intervention content will include: 1) NAFLD education; 2)diet/lifestyle support; 3) T2D medication management; and 4) clinically-indicated liver testing and care.

Intervention feasibility will be evaluated by examining recruitment rates, retention rates, and study visit completion rates. Acceptability will be assessed by survey and through qualitative interviews. The project objectives and intervention are minimal risk. The expected risks will not exceed those of usual care.


Eligibility Criteria:
Inclusion Criteria:

* People who identify as either: Latino/Latina/Hispanic ethnicity and/or Black or African American race
* People with type 2 diabetes (T2D), as defined by ICD-10 codes E11.xx.
* Patients with elevated serum alanine aminotransferase (ALT) within Duke University Healthcare System (DUHS). Elevated ALT will be defined as having at least two ALT ≥40 IU/mL in males or ≥31 IU/mL in females in the preceding 12 months

Exclusion Criteria:

* People with hepatitis B or C infection
* People with known alcohol overuse
* People with current use of chemotherapy or other drugs known to affect liver function
* People who have not been seen by a DUHS Primary Care Physician (PCP) or Endocrinologist in the preceding year.
Observational Study of Oral Cariprazine Capsules to Assess Change in Disease Activity in Adult Participants With Bipolar I Disorder

Bipolar I disorder (BP-I) is a common, chronic, and disabling mental illness with significant morbidity and mortality defined by episodes of mania and depression (or symptoms of both at once, known as mixed features). This prospective, observational study will examine effectiveness, functioning and quality of life outcomes in adult patients with BP-I experiencing a major depressive episode (with or without mixed features) requiring treatment and initiating treatment with cariprazine. It will examine outcomes of cariprazine treatment in a real-world setting in patients with BP-I commonly seen in clinical practices.

Cariprazine (Vraylar) is a medication indicated in the United States and Canada to treat adult patients experiencing manic, mixed or depressive episodes associated with BP-I. This study plans to enroll approximately 170 adult patients with BP-I from the United States and Canada. Cariprazine should be prescribed by the physician under the usual and customary practice of physician prescription. The decision to initiate treatment with cariprazine should be made prior to, and independently from, the patient's decision to participate in the study.

Participants will receive cariprazine as prescribed by their physician. Observational data will be collected during visits which should align to routine standard of care for a duration of up to 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Have a physician-confirmed diagnosis of BP-I, with or without comorbidities.
* Prescribed cariprazine as part of routine clinical practice with the intention of treating as per the approved market label, respective country indications, and by the physician under usual and customary practice of physician prescription.
* Have a Montgomery-Åsberg Depression Rating Scale (MADRS) score \>= 20 at baseline.
* Have a Functioning Assessment Short Test (FAST) score \>= 21 at baseline.
* Naïve to cariprazine in the current major depressive episode.

Exclusion Criteria:

* Have a medical or psychiatric condition, or planned surgical procedure, which will interfere with study participation, as judged by the investigator.
* Have a known contraindication to cariprazine including any of the following:

  * Hypersensitivity to cariprazine or any ingredient in the formulation
  * For all sites, concomitant use of strong cytochrome P450 (CYP) 3A4 inhibitors and inducers
  * For Canadian sites, as per country label, concomitant use of moderate CYP 3A4 inhibitors and inducers
* Current major depressive episode duration \> 12 months.