cyrilzakka/clinical-trials huggingface dataset:
A Multi-centered，Randomized，Double-blind，Placebo-controlled Study to Evaluate the Efficacy and Safety of SHR-1703 in Eosinophilic Asthma

The purpose of this study is to evaluate the Pharmacodynamic, Efficacy and Safety of SHR-1703 in Asthma Patients with Eosinophil Phenotype


Eligibility Criteria:
Inclusion Criteria:

1. At least 12 years of age
2. A minimum weight of 40kg
3. A medical history of at least 1 year that meets the diagnosis of asthma;
4. Current treatment with medium- or high- doses of ICS for at least 6 months and using steadily at least 3 months
5. Current treatment with an additional controller medication, besides ICS, for at least 3 months and using steadily at least 1 month
6. Absolute count of blood eosinophils suggests eosinophilic asthma
7. During the screening period and baseline, pre- BD FEV1% \< 80%
8. During the screening period and baseline, ACQ-6 score indicates asthma poor control
9. History of severe asthma exacerbation within the past 12 months prior to screening
10. Good compliance with eDiary completion
11. Take efficient contraceptive measures
12. Voluntarily sign the informed consent form to participate in this study

Exclusion Criteria:

1. With other condition that could lead to elevated eosinophils
2. With Clinically significant pulmonary diseases
3. With existing immunodeficiency disease
4. With other clinically significant diseases that may affect lung function
5. With uncontrolled severe cardiovascular and cerebrovascular diseases
6. With uncontrolled hypertension and/or diabetes
7. With exacerbation, allergic rhinitis or sinusitis attacks, or clinical significant infection requiring intervention during 4 weeks prior to randomization
8. Recent major surgeries or surgical plans during the study period, or treatment measures that investigators believe may affect subject evaluation
9. Existing parasitic infections
10. Diagnosed as malignant tumor within the first 5 years of randomization
11. Significant abnormalities in screening period or baseline laboratory tests
12. Screening period or baseline ECG QTc prolongation
13. Prohibited drugs using during the pre randomization period
14. Participated in other clinical trials within 30 days prior to screening and used research drugs containing active ingredients, or was still within 5 half lives of the research drug at the time of screening
15. Smoking or quitting smoking for less than 6 months during screening, or previous smoking history ≥ 10 pack years
16. History of drug use, alcoholism, or substance abuse within the past year prior to screening
17. Allergic or intolerant to IL-5 monoclonal antibodies or other biological agents
18. Pregnant or lactating subjects
19. Other reasons why the researcher deemed it unsuitable for conducting this experiment
Feasibility of a Community-based Dance Program for Latino Older Adults

The objective of this study is to evaluate the feasibility and preliminary effectiveness of Activate Bailando, a 6-week community-based dance class offered in Spanish to older adults. 20 older adults in the Madison, Wisconsin area who are enrolled in Activate Bailando will complete a pre-and post-program test within 10 days for program start and completion.

The primary aim is to evaluate the feasibility of the Activate Bailando program based on measures of recruitment, retention, attendance, and acceptability.

The secondary aim is to evaluate the preliminary effectiveness of the program on metrics of balance, mobility, social connectedness, and fear of falling.

Eligibility Criteria:
Inclusion Criteria:

* Being over the age of 55
* Willing and able to participate in the Activate Bailando class
* Willing and able to complete data collection before and after the program

Exclusion Criteria:

* Not Being over the age of 55
* Not willing and able to participate in the Activate Bailando class
* Not willing and able to complete data collection before and after the program
Oral Rivaroxaban in Children With Venous Thrombosis

The purpose of this study is to find out whether rivaroxaban is safe to use in children and how long it stays in the body. There will also be a check for bleeding and worsening of blood clots.


Eligibility Criteria:
Inclusion Criteria:

* Children aged 6 to \< 18 years with documented symptomatic or asymptomatic venous thrombosis treated for at least 2 months or, in case of catheter related thrombosis, treated for at least 6 weeks with LMWH (low molecular weight heparin), , fondaparinux and/or VKA (vitamin K antagonist).
* Informed consent provided and, if applicable, child assent provided

Exclusion Criteria:

* Active bleeding or high risk for bleeding contraindicating anticoagulant therapy
* Symptomatic progression of venous thrombosis during preceding anticoagulant treatment
* Planned invasive procedures, including lumbar puncture and removal of non peripherally placed central lines during study treatment
* An estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m2
* Hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk or ALT \> 5x upper level of normal (ULN) or total bilirubin \> 2x ULN with direct bilirubin \> 20% of the total
* Platelet count \< 50 x 10\^9/L
* Hypertension defined as \> 95th age percentile
* Life expectancy \< 3 months
* Concomitant use of strong inhibitors of both cytochrome P450 isoenzyme 3A4 (CYP3A4) and P-glycoprotein (P-gp), i.e. all human immunodeficiency virus protease inhibitors and the following azole antimycotics agents: ketoconazole, itraconazole, voriconazole, posaconazole, if used systemically
* Concomitant use of strong inducers of CYP3A4, i.e. rifampicin, rifabutin, phenobarbital, phenytoin and carbamazepine
Is Mitral Annuloplasty an Effective Treatment for Severe Atrial Functional MR?

Atrial functional mitral regurgitation (MR) is caused by annular dilatation and flattering associated with altered atria/annulus dynamics in patients with severely dilated left atrium and normal leaflets anatomy. Inadequate leaflets adaption is considered a mechanistic culprit as well. Prevalence of at least moderate atrial functional MR varies between 4.7% and 7% in patients with permanent and long standing persistent atrial fibrillation (AF) and is even higher in patients with Heart Failure with preserved Ejection Fraction (HFpEF). Unlike secondary MR in the setting of left ventricular disease, results of surgical treatment of severe atrial functional MR has remained largely unspoken.

The aim of this study is to analyze short and mid-term results of isolated annuloplasty in patients with severe, symptomatic atrial functional MR, in comparission to a matched cohort of patients with secondary MR.


Eligibility Criteria:
Atrial MR group Inclusion criteria

* Adult patients, underwent mitral annuloplasty for atrial functional mitral Anatomical criteria
* Annular dilatation with anterior-posterior diameter (AP) in systole \>35mm
* Ratio of AP diameter in systole to anterior leaflet length in diastole \>1.3
* Normal leaflets anatomy
* Mild fibrosis may be present
* A small cleft may be present as a result of annular dilatation Functional criteria
* Normal leaflet mobility (Carpentier type I)
* Coaptation depth \<10mm
* Absence of ventricular tethering
* Centrality of the regurgitant jet Atrial and ventricular characteristics
* Left atrium diameter \> 40 mm
* Normal systolic function of the left ventricle
* Mild left ventricular systolic dysfunction Mild LV (tachycardia induced) with EF \>45%
* Absence of regional abnormalities in left ventricular wall motion Clinical criteria
* Persistent, long-standing persistent, or permanent atrial fibrillation

Exclusion criteria

* Degenerative MR including congenital clefts
* LVEF \< 45%
* Ventricular tethering
* Coaptation depth \>10 mm
* Regional abnormalities in left ventricular wall motion
* Sinus rhythm
* Presence of coronary artery disease
* Absence of annular dilatation

Non-atrial MR group Inclusion criteria

* Adult patients underwent cardiac surgery for non-atrial functional mitral regurgitation in the setting of an idiopathic or ischemic cardiomyopathy

Exclusion criteria

* FE\<40%
* Concomitant coronary artery bypass graft
* Age \<65 years and \>75years
* Treated with annuloplasty + edge-to-edge surgery
* Sinus rhythm
Cataract Surgery and Inflammation - the Role for Preoperative NSAIDs (Pre-CIN)

The pre-CIN trial is a randomized clinical three-arm trial comparing inflammation and cystoid macular edema for the medication regimens preoperative and postoperative topical NSAIDs to only postoperative topical NSAIDs to postoperative topical NSAIDs and steroids in patients undergoing cataract surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be 18 years and older at the time of the signing of the informed consent. There is no upper age limit.
* Scheduled for standard phacoemulsification cataract surgery (group 1 - 3)
* Scheduled for combined phacoemulsification cataract surgery and MIGS stent (group 4)
* Ability to cooperate fairly well during the examinations
* Willing to participate in the study and capable of giving informed consent, which includes compliance with the requirements and restrictions in the informed consent form (ICF) and in this protocol.

Exclusion Criteria:

* Contraindications for use of any medication (as listed in the approved SPC, e.g. allergy, pregnancy, breastfeeding)
* Pregnancy
* Diabetes
* Mature cataract
* Active or chronic uveitis with recommendation for steroid treatment
* Previous trabeculectomy
* Other ophthalmological conditions and/or complicating factors requiring steroid treatment (group 1 - 3)
* Cornea pathology requiring specific medication regimens (e.g. herpes pathology, previous corneal transplantation)

Patients with complications or other complicating factors during surgery that causes the surgeon to demand both NSAIDs and steroid treatment will be excluded from the main analysis. These patients will be followed postoperatively as part of the study and included in additional analyses (for example as part of an intention to treat analysis).

For patients scheduled for cataract surgery in both eyes, only the first operated eye will be included, however, both eyes will be examined.
Clinical Utility of VI-RADS in Diagnosis of MIBC

Bladder Cancer (BCa) is the 9th most common cancer worldwide. In general, BCa is presented as a non-muscle invasive bladder cancer (NMIBC) in 70% of patients and treated with transurethral resection of bladder tumor (TUR-BT). However, in cases of muscle invasive bladder cancer (MIBC), radical cystectomy (RC) is the gold standard of treatment. Therefore, It is important to distinguish MIBC from NMIBC.

To date, pathologic staging is based on the result of TUR-BT before RC. However, it is operator dependent, thus residual cancer may be remained depending on surgical experience. Therefore, about 7%-30% patients of MIBC can be underestimated with NMIBC, and it can be increased to 45% if the muscle is not resected. Consequently, it has been raised the need for imaging test to overcome diagnostic limitations.

Multiparametric magnetic resonance imaging (mpMRI) has been widely used in the field of diagnosis of BCa. In 2018, the Vesical Imaging Report and Data System (VI-RADS) was published using T2-weighted imaging (T2WI), diffusion-weighted imaging (DWI), and dynamic contrast enhanced (DCE) imaging, and 5-point VI-RADS scoring system has been proposed and reported as an imaging test useful for assessing muscle involvement in primary bladder cancer Therefore, in this study, we investigate the diagnostic performance of the VI-RADS scoring system that can differentiate NMIBC from MIBC in primary bladder cancer.


Eligibility Criteria:
Inclusion Criteria:

* older than 18 years
* primary bladder cancer in cystoscopy
* suitable for MRI and TUR-BT
* agreement to participate in the study and signing of an informed consent form

Exclusion Criteria:

* history of TUR-BT
* previous radiation and/or chemotherapy for bladder cancer
* Not suitable for MRI or TUR-BT
Pharmacological Manipulation of Intrahepatic Arterial Blood Flow in HCC

Dr Rajan is investigating a new method to improve local treatment of liver cancer. There is evidence that a drug, norepinephrine (NE), has the ability to shrink down normal liver blood vessels, but leave tumor vessels wide open. In patients with primary liver cancer, NE will be injected directly in the artery that nourishes the liver and the tumor. Real time blood flow will be measured using an advanced CT scanner to demonstrate the NE effect on blood vessels. If Dr Rajan's hypothesis is confirmed, this drug has great potential to benefit patients during local delivery of chemotherapy in the liver artery, diverting it away from normal liver and towards the tumor, resulting in less complications and improved tumor kill.

This study aims to evaluate the blood flow modifications in liver following injection of norepinephrine in the hepatic artery. These blood flow variations have never been dynamically evaluated before. If indeed blood flow modulation in liver is favorable, the use of norepinephrine prior to localized chemotherapy has great potential to enhance treatment and diminish side effects. Patients with hepatocellular carcinoma, a primary liver cancer, will be selected for this study. Included patients will have a trans-arterial chemoembolization (TACE) procedure scheduled as treatment for their cancer. During their procedure, they will be brought to an advanced CT-scanner. CT perfusion imaging will be performed prior, and after the injection of the study drug in the liver artery. Patient's treatment will then be completed. Perfusion color maps will illustrate blood flow. Perfusion values will be correlated to see how the drug modulates blood flow in tumor and in normal liver.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven HCC\< or confident diagnosis of HCC on multi-phasic CT or MRI
* Selection criteria for chemoembolization must be met, including adequate coagulation profile and serum creatinine, patent portal vein, no severe contrast allergy, cirrhosis Child A or B.
* 5 or less untreated nodular hepatic tumors within the lobe to undergo chemoembolization. Larger nodule must be equal or over 3 cm.
* Patient must be able to provide written, informed consent.

Exclusion Criteria:

* Symptoms or history of ischemic cardiac disease or arrhythmia
* Uncontrolled hypertension
* Pregnancy or desire to get pregnant
* Severe COPD, FEVS lower than 30%
* Prior documented hypersensitivity to norepinephrine
* Patients receiving MAO inhibitors, or anti-depressants of the triptyline or imipramine types
The International Diabetes Closed Loop (iDCL) Trial: Protocol 1

The objective of the study is to assess the efficacy and safety of home use of a Control-to-Range (CTR) closed-loop (CL) system.

The protocol is a 3-month parallel group multi-center randomized trial designed to compare Control-to-Range (CTR) closed-loop (CL) with sensor augmented pump therapy (SAP). Approximately 126 subjects will be entered into the randomized trial at approximately seven clinical sites in the United States, such that at least 110 subjects complete the randomized trial. A maximum of 200 subjects may be enrolled in the study in order to achieve the goal of randomizing 126 subjects.

In order to have a broad range of glycemic control among the subjects, a study goal will be to have a minimum of 50 subjects with HbA1c ≥ 7.5% and 50 with HbA1c \< 7.5%.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year and using insulin for at least 1 year
2. Use of an insulin pump for at least 6 months
3. Age ≥14 years old
4. HbA1c level \<10.5% at screening
5. For females, not currently known to be pregnant
6. Willingness not to add glucose-lowering agents (such as Pramlintide, Metformin, GLP-1 analogs, SGLT2 inhibitors) during the study
7. Willingness, if not assigned to the closed-loop group, to avoid use of any closed-loop control system for the duration of the clinical trial
8. Willingness to suspend use of any personal CGM for the duration of the clinical trial once the unblinded study CGM is in use
9. Willingness to establish network connectivity on at least a weekly basis either via local Wifi network or via a study-provided cellular service
10. Currently using no insulins other than one of the following rapid-acting insulins at the time of enrollment: insulin lispro (Humalog), insulin aspart (Novolog), or insulin glulisine (Apidra)
11. Investigator has confidence that the subject can successfully operate all study devices and is capable of adhering to the protocol
12. For subjects less than 18 years old, living with one or more parent/legal guardian (referred to subsequently as diabetes care partner) committed to participating in study training for emergency procedures for severe hypoglycemia and able to contact the subject in case of an emergency

Exclusion Criteria:

1. Medical need for chronic acetaminophen
2. Use of any glucose-lowering agent (such as Pramlintide, Metformin, GLP-1 analogs, SGLT2 inhibitors) in the 3 months prior to enrollment
3. Hemophilia or any other bleeding disorder
4. A condition, which in the opinion of the investigator or designee, would put the participant or study at risk including any contraindication to the use of any of the study devices per FDA labeling
5. Participation in another pharmaceutical or device trial at the time of enrollment or during the study
6. Use of a closed-loop system within the last month prior to enrollment
7. Employed by, or having immediate family members employed by TypeZero Technologies, LLC
Tazemetostat Expanded Access Program for Adults With Solid Tumors

Patients with a diagnosis listed under "conditions" below are eligible to be considered for the EAP. These conditions must be serious or life-threatening at the time of enrollment and appropriate, comparable, or satisfactory alternative treatments must have been tried without clinical success. Patients with conditions not listed under "conditions" below are not eligible for the tazemetostat EAP.


Eligibility Criteria:
Inclusion Criteria:

1. Age (at the time of consent): \>18 years of age.
2. They are unable to participate in tazemetostat clinical trials for their condition.
3. Can provide signed written informed consent.
4. Documented loss of INI1 or SMARCA4 confirmed by IHC, or molecular confirmation of tumor bi-allelic INI1 or SMARCA4 loss or mutation when INI1 or SMARCA4 IHC is equivocal or unavailable.
5. Female patients of childbearing potential should:

   * Agree to practice one highly effective method of contraception and one additional effective (barrier, for example condom or diaphragm with spermicide) method at the same time, from the time of providing voluntary written informed consent through (30 days or 5 half-lives, whichever is longer) after the last dose of tazemetostat, and
   * Have a negative beta-human chorionic gonadotropin (β-hCG) pregnancy test at time of screening and within 14 days prior to planned first dose of tazemetostat (urine or serum test is acceptable however, positive urine tests must be confirmed with serum testing), and
   * Agree to use effective contraception from start of screening until 30 days following the last dose of tazemetostat and have a male partner who uses a condom, or
   * Practice true abstinence, (when this is in line with the preferred and usual lifestyle of the patient or
   * Have a male partner who is vasectomized.
6. Male patients with a female partner of childbearing potential should:

   * Be vasectomized, or
   * Agree to use condoms from first dose of tazemetostat until 30 days following the last dose of tazemetostat, or
   * Have a female partner who is NOT of childbearing potential.

Exclusion Criteria:

1. Is unwilling to exclude grapefruit juice, Seville oranges and grapefruit from the diet and all foods that contain those fruits from time of enrollment to while on the EAP.
2. Is currently taking any prohibited medication(s) as described in section 6.3.
3. Has known hypersensitivity to any of the components of tazemetostat or other inhibitor(s) of EZH2.
4. Has thrombocytopenia, neutropenia, or anemia of grade ≥3 (per CTCAE 4.03 criteria) within the past month, or any prior history of myeloid malignancies, including myelodysplastic syndrome (MDS).
5. Is known to have any abnormalities associated with MDS (e.g. del 5q, chr 7 abn) and MPN (e.g. JAK2 V617F) observed in cytogenetic testing and DNA sequencing.
6. Has a prior history of T-LBL/T-ALL.
7. For female patients of childbearing potential: Is pregnant or nursing.
8. For male patients: Is unwilling to adhere to contraception criteria from time of enrollment in study to at least 30 days after last dose of tazemetostat.
Pain Perception in Alzheimer's Disease

The purpose of this study is to determine response to pain in Alzheimer's disease.We plan to study the effect of diffuse noxious inhibitory controls(counterirritation phenomenon)and the autonomic nervous system reaction(reflected by the heart rate) in Alzheimer's disease. The study's hypothesis is that pain perception and autonomic nervous system reaction are altered in Alzheimer's disease.


Eligibility Criteria:
Inclusion Criteria:

- Clinical diagnosis of Alzheimer's disease Must be able to understand a simple pain scale

Exclusion Criteria:

Neuropathy Psychotropic drugs use -
Rotator Cuff Tears Treated with Long Head of the Biceps Reinforcement

The increase of the population life expectancy and the active lifestyle adopted in recent years have contributed to the higher incidence of rotator cuff injuries. For large (\>3 cm) and extensive (\>5 cm) injuries of the rotator cuff, even after complete or partial repair, the chances of failure reach 94%.

An alternative in rotator cuff injuries is the use of the long head of the biceps (LHB) as an autologous graft to increase the healing rate and the final outcomes.

The primary objective is to compare the functional results, according to the ASES score, between patients who use or not the long head biceps brace for complete repairs of large and extensive rotator cuff tears.

The secondary objectives are to compare the groups according to structural results by MRI and functional results by the UCLA score.

A prospective randomized study will be carried out in a 1:1 ratio between groups. Patients with large and extensive rotator cuff injuries will be selected at the Shoulder and Elbow clinic of Pedro Ernesto University Hospital (HUPE-UERJ), during outpatient care.

Patients with an intact long head of the biceps will be randomized into two groups, according to the use or not of the tendon: complete repair with LHB tendon reinforcement and complete repair without reinforcement. All patients will be operated by the same surgeon.

All selected patients will be explained what the research is about by a research assistant not involved in the treatment and will be offered the option to participate or not.

The "American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form" (ASES) scale will be adopted as the primary outcome. The "Modified University of California at Los Angeles Shoulder Rating Scale" (UCLA) and the assessment of tendon healing with magnetic resonance imaging at 6 months after surgery, using the classification of Sugaya et al. will be secondary outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Long head tendon of biceps intact;
* Large or extensive posterosuperior rotator cuff injuries according to the classification of DeOrio and Cofield;20
* Fatty degeneration of the ≦2 supraspinatus muscle according to the classification of Goutallier.21

Exclusion Criteria:

* Active or previous infection in the affected shoulder;
* Patients unable to understand preoperative questionnaires;
* Patient who does not undergo at least 1 postoperative evaluation.
* Injury where complete repair of the rotator cuff is not possible;
* Rupture of the LHB tendon diagnosed intraoperatively.