cyrilzakka/clinical-trials huggingface dataset:
DLCL002 Protocol for Patients With High Risk Aggressive B-cell Lymphoma

Patients eligible for the study will receive R-DA-EDOCH as the induction therapy and be evaluated by PET CT after the fourth cycle. Patients achieve CR at interim-PET(Deauville score 1-3) will receive either ASCT or the remaining 4 cycles of R-DA-EDOCH, while those achieve PR(Deauville score 4-5) will be rescued by two courses of R(2)-DHAP and then be revaluated by the second interim-PET. Patients who achieved CR+good PR(Deauville score 4) after the rescue therapy will be consolidated with ASCT,and those remain in PR(Deauville score 5) will receive other rescue treatments(including ASCT+CAR T).

Survival for patients with high risk aggressive B-cell lymphoma is still unsatisfied. Dose-intensified immunochemotherapy might improve the outcome. But for patients who could not achieve CR after the dose-intensified induction therapy, the prognosis is poor. The DLCL002 protocol is a total therapy which including induction therapy, rescue therapy and autologous stem cell transplantation. Patients eligible for the study will receive R-DA-EDOCH as the induction therapy and be evaluated by PET CT after the fourth cycle. Patients achieve CR at interim-PET(Deauville score 1-3) will receive either ASCT or the remaining 4 cycles of R-DA-EDOCH, while those achieve PR(Deauville score 4-5) will be rescued by two courses of R(2)-DHAP and then be revaluated by the second interim-PET. Patients who achieved CR+good PR(Deauville score 4) after the rescue therapy will be consolidated with ASCT,and those remain in PR(Deauville score 5) will receive other rescue treatments(including ASCT+CAR T).

Eligibility Criteria:
Inclusion Criteria:

* Histological confirmed aggressive B-cell lymphoma with one of the following subtypes:

  1. diffuse large B-cell lymphoma, NOS with at least one poor prognostic factor as follows:

     1. aaIPI 2\~3(≤60 years) or IPI 3\~5(\>60 years);
     2. double protein expression lymphoma(IHC MYC≥40% and BCL2≥50%） with Ann Arbor stage of III\~IV or aaIPI 2\~3 or IPI 3\~5;
     3. CD5+ DLBCL.
  2. high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements;
  3. high-grade B-cell lymphoma, NOS
  4. transformed lymphoma(no prior treatment)
* Age 18 to 65 years
* ECOG-PS: 0\~2
* Life-expectancy \> 3 months

Exclusion Criteria:

* Patients with central nerves system involvement
* HIV positivity
Remote Ischaemic Conditioning on Blood Pressure Control in Chronic Kidney Disease Patients

Chronic kidney disease (CKD) is one of the leading causes of death and disability in Singapore and worldwide. Hypertension is commonly inadequately controlled in patients with CKD and this is associated with CKD progression and cardiovascular complications. Daily episodes of Remote ischaemic conditioning (termed chronic RIC or CRIC) using transient limb ischaemia/reperfusion applied for 1 to 12 months have been shown to lower systemic blood pressure (SBP), prevent stroke and reduce post-myocardial infarction left ventricular (LV) remodelling in experimental and clinical studies. In the ERIC-BP-CKD feasibility and efficacy study, we hypothesise that CRIC administered for 28 days will lower systemic blood pressure and improve blood pressure control in patients with CKD and hypertension.

Chronic kidney disease (CKD) is one of the leading causes of death and disability in Singapore and worldwide. CKD patients often suffer with inadequately controlled hypertension, the presence of which is associated with cardiovascular complications such as left ventricular (LV) hypertrophy, cardiac failure, and stroke. As such, novel treatments are required to improve blood pressure control in order to improve health outcomes in CKD patients.

Remote ischaemic conditioning (RIC) using transient limb ischaemia/reperfusion has been shown to protect the kidney and microvasculature in experimental and clinical studies, and daily episodes of RIC (termed chronic RIC or CRIC) applied for 1 to 12 months have been shown to lower systemic blood pressure (SBP), prevent stroke and reduce post-myocardial infarction left ventricular (LV) remodelling in experimental and clinical studies. Whether CRIC can reduce SBP in hypertensive patients with CKD is not known. In the ERIC-BP-CKD feasibility and efficacy study, we hypothesise that CRIC administered for 28 days will lower systemic blood pressure and improve blood pressure control in patients with CKD and hypertension.

In this study, subjects will be randomised in a 1:1 ratio to receive therapy from either the active autoRIC® Device or identical sham autoRIC® Device.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent
2. Aged 21 years and older
3. CKD (all stages 1-4)
4. On treatment for hypertension and automated office BP (AOBP) ≥ 140mmHg (this will be determined by an automated oscillometric BP device)

Exclusion Criteria:

1. Patients with polycystic kidney disease
2. Atrial fibrillation
3. Patients on long-acting sulphonylureas (eg glibenclamide) or nicorandil (as these medications may interfere with the protective effect of CRIC).
4. Patients recruited into another study which may impact on this study.
5. Symptomatic peripheral arterial disease affecting the upper limbs (given nature of upper-limb CRIC protocol).
6. Renal transplant / Dialysis patients
7. Pregnant patients
8. Patients on any anti-coagulant medications (e.g. Warfarin)
9. For echo sub-study only: Prior myocardial infarction, BMI \> 30kg/m2, known severe acrdiac valve disease, known severely impaired LVEF \<35%
Extension Study to Provide Adjuvant Treatment Following Neoadjuvant Treatment and Surgical Resection in Protocol TX05-03

This is an extension study to provide adjuvant treatment with single agent Herceptin or TX05 and assess continued safety and immunogenicity in subjects with HER2-positive early breast cancer following neoadjuvant treatment and surgical resection in Protocol TX05-03.


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent.
* Females ≥ 18 years of age.
* Completed neoadjuvant treatment (regardless of treatment arm) in the TX05/ Herceptin neoadjuvant study and the investigator believes the subject requires continued access to single agent trastuzumab in order to continue deriving clinical benefit.
* Successfully undergone surgical resection of their primary tumor with no evidence of residual disease (as determined by local assessment) and no other adjuvant therapy, other than trastuzumab, is planned. However, subjects will be allowed to receive hormonal therapy if they have hormone receptor positive tumors. Subjects will also be allowed to receive adjuvant radiation therapy, if required by their treating physician.
* Able to comply with the study protocol.
* Female subjects of childbearing potential must have a negative serum pregnancy test within 14 days of first administration of study drug and agree to use effective contraception (hormonal contraceptive, intrauterine device, diaphragm with spermicide, or condom with spermicide) throughout the study period and for 7 months after last administration of study drug.

Exclusion Criteria:

* Breast cancer metastases or residual disease post operatively (as determined by local assessment).
* History or presence of a medical condition or disease that in the investigator's opinion would place the subject at an unacceptable risk for study participation.
* Lactating or pregnant female.
* Women of childbearing potential who do not consent to use highly effective methods of birth control (e.g. true abstinence \[periodic abstinence {e.g. calendar ovulation, symptothermal, post-ovulation methods} and withdrawal are not acceptable methods of contraception\], sterilization, or other non-hormonal forms of contraception) during treatment and for at least 7 months after the last administration of study drug. Subjects must agree to not breast-feed while receiving study drug.
* Any condition that in the opinion of the Investigator represents an obstacle for study conduct and/or represents a potential unacceptable risk for subjects.
The Effect of "Cerclage Pacing" for the Heart Failure Patients Who Need Cardiac Resynchronization Therapy (CRT)

trans-coronary sinus intraseptal pacing (cerclage pacing)

This study is aimed at looking at the effect of "Cerclage pacing" for the heart failure patients who need cardiac resynchronization therapy (CRT). The study hypothesis is that parahisian pacing by 'cerclage pacing' may have a similar benefit as is seen with permanent Hisian pacing

Eligibility Criteria:
Inclusion Criteria:

* who need cardiac resynchronization therapy (CRT) or CRT-non responder
* Left bundle branch block \[LBBB\]) \> 120ms of QRS width
* Ejection fraction (EF) \< 35%
* NYHA class III-IV in spite of optimal medical Tx

Exclusion Criteria:

* Unsuitable coronary vein anatomy on cardiac CT
* Subjects with prosthetic mechanical tricuspid valve
* Active infection
* Life expectancy less than 6 months
Pars Plana Vitrectomy (PPV) Versus Preoperative Intravitreal Bevacizumab Plus PPV to Treat Diabetic Tractional Retinal Detachment (IBETRA)

The purpose of this study is to compare the amount of intraoperative intraocular bleeding during 23-gauge pars plana vitrectomy (PPV) for diabetic traction retinal detachment (TRD) with and without preoperative intravitreal bevacizumab treatment.


Eligibility Criteria:
Inclusion Criteria:

* Macular traction retinal detachment lasting three months or less secondary to diabetic retinopathy.

Exclusion Criteria:

* Massive vitreous hemorrhage preventing from detailed posterior pole examination;
* Previous intra-ocular surgery other than cataract surgery
* Hemodialysis, known bleeding disorders or use of anticoagulants drugs other than aspirin
* Prothrombin time, partial thromboplastin time or platelet count without normal limits
* History of previous thromboembolic events
A Study to Detect Advanced Liver Disease Via AI-enabled Electrocardiogram

The overall objectives of this study are to determine the effectiveness of ACE 2.0 model in early detection of advanced liver fibrosis, and to determine the acceptance and barriers for use of an AI-enabled algorithm for prediction of liver disease in primary care.

A pragmatic, cluster randomized trial in 45 Mayo Clinic primary care practices will be conducted over a period of 6 months with 6 months of follow up. Care teams will be randomized 1:1 to intervention or usual care, stratified by region and patient volume. In the intervention arm, the DULCE score will be used to alert consenting providers to the likelihood of advanced liver disease with a recommendation for a FibroTest-ActiTest. The primary endpoint will be detection of advanced liver disease. Secondary outcomes will include completion of noninvasive fibrosis assessment tests and hepatology referral within 180 days of ECG, new diagnosis of liver disease stratified by etiology (nonalcoholic fatty liver disease, alcohol-associated liver disease, hepatitis C, and others) and severity (compensated with and without clinically-significant portal hypertension, and decompensated disease), initiation of prophylactic nonselective beta-blockers and imaging for hepatocellular carcinoma surveillance, according to published society guidelines. Post-study surveys to participating clinicians will be applied.

Eligibility Criteria:
Criteria:

Inclusion Criteria:

* Primary care clinicians (physicians, nurse practitioners, and physician assistants).
* Part of a team that cares for adult patients (≥18 years).
* Have the ability to order ECG.
* Consent will be obtained from primary care clinicians.
* Patients' data will be collected from electronic medical records (EMR).
* Adult patients (≥ 18 years) undergoing an ECG for any indication over a period of 6 months will be included.

Exclusion Criteria:

* Patients with known cirrhosis based on noninvasive fibrosis assessment tests, liver biopsy or complications of decompensated disease, or with a documented history of cirrhosis identified by clinical notes.
Continence Across Continents to Upend Stigma and Dependency

To determine whether women exposed to the continence promotion intervention will report improved urinary symptoms and quality of life, and lower incontinence-related stigma and falls than women who receive a control intervention at one-year post-intervention.

This is a cluster-randomized 4-site intervention study testing the effect of a continence-promotion intervention on:

1. Improved urinary symptoms and quality of life
2. Reduction in falls
3. Reduction in stigma

A cost-effectiveness component will also be included

Eligibility Criteria:
Inclusion Criteria:

* Women
* 65 years and older
* Urinary incontinence at least once weekly

Exclusion Criteria:

* Living in residential or long-term care
* Received treatment for incontinence within the past year
* Dementia or other neurological conditions that preclude the ability to provide -Informed consent
Flibanserin Evaluation Over 28 Additional Weeks in Hypoactive Sexual Desire Disorder

Safety profile of flibanserin over 28 additional weeks Distribution of preferred dose regimens


Eligibility Criteria:
Inclusion Criteria:

* Women with a primary diagnosis of HSDD who still needs to be treated according to the investigator's opinion and willing to continue in this study. This continuation requires adequate compliance, in the Investigators judgement, with trial medication and the trial visit required in the parent clinical trial (Visit 1 to visit 9).
* Patients must have used a medically acceptable method of contraception \[i.e., double barrier method (e.g., diaphragm or condom and spermicide), hormonal therapy (subcutaneous, injectable, intra-vaginal, or oral contraceptive), intrauterine device, tubal sterilization, or partner's surgical sterilization\] for at least 3 months before the Screen Visit and continue to use that medically acceptable method of contraception during the trial.

Exclusion Criteria:

* Patients with a history of MDD within 6 months prior the Screen Visit or a score of 14 on the Beck Depression Inventory II, or a history of suicide attempt according to the Beck Scale for Suicide Ideation, or patient with any non-zero statement in the first five items for the Beck Scale for Suicide Ideation.
* Patients must have a clinically acceptable Pap smear as read by a cytology facility (no evidence of malignancy or squamous intraepithelial lesions) within 6 months before the Inclusion Visit.
* Patients with findings at the Screen Visit of pelvic inflammatory disease, urinary tract or vaginal infection/vaginitis, cervicitis, interstitial cystitis, vulvodynia, or significant vaginal atrophy.
* Patients experiencing major life stress (including parenting pressure, eldercare, loss of income, death of a family member, etc.) or relationship discord that could interfere with sexual activity, except distress about HSDD.
* Clinically significant ECG abnormalities at the Screen Visit, according to the investigators opinion or the cardiologist who have performed the ECG. The following ECG values are considered to be exclusionary: QTc intervals \>480 milliseconds (ms), PR intervals \>240 ms, and QRS intervals \>110 ms.
Post Market Clinical Follow-up (PMCF) Study of Clareon Vivity & Clareon PanOptix

The purpose of this Post-Market Clinical Follow-up study is to describe the long-term safety and performance of the Clareon Vivity and Vivity Toric and Clareon PanOptix and PanOptix Toric IOLs.

Subjects will be recruited from a population that has already undergone lens implantation. Retrospective data will be collected from the pre-operative and surgical visits and any safety outcomes reported prior to enrollment. Prospective data will be collected from time of study enrollment through the Year 3 follow-up visit.

Eligibility Criteria:
Key Inclusion Criteria:

* Subject or legally authorized representative must be able to understand and sign an approved Informed Consent Form.
* Subject must have had bilateral implantation of Clareon Vivity, Clareon Vivity Toric, Clareon PanOptix, or Clareon PanOptix Toric IOLs between 3-6 months prior to enrollment.
* Subject must have a documented medical history and required pre-operative baseline information available for retrospective data collection.
* Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

* Subject is currently participating in another investigational drug or device study.
* Subject has had corneal refractive surgery after Clareon Vivity, Clareon Vivity Toric, Clareon PanOptix, or Clareon PanOptix Toric IOL implantation.
* Subject is pregnant at the time of enrollment.
* Other protocol-defined exclusion criteria may apply.
EGFR-TKI Concurrent With/Without WBRT in Brain Metastasis From NSCLC

This is a multi-center phase III randomized controlled study, designing to access whether the efficacy of EGFR-TKI alone on patients with brain metastasis from non-small cell lung cancer (NSCLC) harboring EGFR mutant type is not inferior to EGFR-TKI concurrent with whole brain radiotherapy (WBRT), the primary end point is intracranial PFS (iPFS), while secondary outcomes included overall survival (OS), objective response rate (ORR), evaluation of cognitive function, quality of life (QoL) and adverse events.


Eligibility Criteria:
Inclusion Criteria:

* Patients who was confirmed non-small cell lung cancer (NSCLC) by histology or cytology, harboring EGFR mutant type (19 and/or 21 exon mutation).
* Patients who was confirmed with asymptomatic, treatment naive brain metastasis (didn't receive any treatment after diagnosed with brain metastasis) by MRI, couldn't receive operation or stereotactic radiosurgery（SRS）.
* Appraisable disease, that is there must be at least one lesion with the longest diameter\>10mm in brain (by brain MRI).
* Adult patients (18 to 75 years old). Eastern Cooperative Oncology Group（ECOG） performance status 0 to 2. Life expectancy of at least 12 weeks. Haemoglobin \> 10g/dl, absolute neutrophil count (ANC) \> 1.5 x 10\^9/L, platelets \> 100 x 10\^9/L; total bilirubin \< 1.5x upper limit of normal (ULN). Alanine aminotransferase（ALT） and aspartate aminotransferase（AST）\< 1.5x ULN in the absence of liver metastases, or \< 5x ULN in case of liver metastases. Creatinine clearance \> 60ml/min (calculated according to Cockcroft-gault formula).
* Patients should be contraceptive during the period of the trial.

Exclusion Criteria:

* Patients who had received brain radiotherapy or EGFR-TKI before.
* Patients who can't receive WBRT.
* Uncontrolled intracranial hypertension after steroid or dehydration therapy.
* Patients who take phenytoin, Carbamazepine, Rifampicin, Barbital, or St John's Wort which will interfere with the metabolism of TKI.
* Patients with interstitial lung disease, significant ocular disease, or serious uncontrolled systematic disease.
* Patients who can't take oral tablets, with active peptic ulcer diseases.
* Pregnancy or breast-feeding women.
Effects of Aerobic Exercise on Cognitive Function and Brain-derived Neurotrophic Factor in Young Adults

The present study will investigate the effects of aerobic exercise on cognition and growth factors including brain-derived neurotrophic factor (BDNF) in young adults aged 15-21 years. The included subjects will be randomized to three different groups including one control group and two exercise groups. Subjects randomized to the exercise groups will complete 30 minutes of aerobic exercise 3 times a week for 9 weeks incorporating low (group I) or high (group II) intensity aerobic exercise. The exercise will be conducted as running or indoor cycling (supervised). At baseline and 9-weeks follow-up all subjects will complete two cognitive tests (measures of concentration and sustained attention), a maximal cycling test (direct measures of VO2max), an intelligence quotient test, anthropometric measures, fasting blood samples and blood samples immediately following the cycling test. The blood samples will be analyzed for growth factors including BDNF and metabolic factors.


Eligibility Criteria:
Inclusion Criteria:

* age 15-21

Exclusion Criteria:

* injury preventing one from being physically active
SVC Occlusion in Subjects With Acute Decompensated Heart Failure

Safety and performance evaluation of the preCARDIA System for patients with ADHF.

The objective of this early feasibility study is to evaluate the safety and performance of the preCARDIA System for Superior Vena Caval (SVC) intermittent mechanical occlusion as a therapeutic approach in significantly congested subjects with Acute Decompensated Heart Failure (ADHF), who are not diuresing adequately.

Eligibility Criteria:
Inclusion Criteria:

* NYHA Class III-IV heart failure
* Subjects with inadequate diuresis
* Stage C-D systolic heart failure

Exclusion Criteria:

* Active myocardial ischemia or acute coronary syndrome (ACS)
* Severe aortic or mitral valve insufficiency
* Severe peripheral vascular disease
Oxcarbazepine 600 mg Tablets Under Fasting Conditions

The objective of this study is to evaluate the comparative bioavailability between Oxcarbazepine 600 mg Tablets (test) and Trileptal® 600 mg Tablets (reference) after a single-dose in healthy subjects under fasting conditions.

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Eligibility Criteria:
Inclusion Criteria:

* Healthy, non-smoking male and female subjects, 18 years of age or older.
* BMI greater than or equal to 19 and less than or equal to 30.
* Negative for:

  * HIV.
  * Hepatitis B surface antigen and Hepatitis C antibody.
  * Using drugs of abuse test (marijuana, amphetamines, barbiturates, cocaine, opiates, benzodiazepines and methadone).
  * Urine cotinine test
  * Serum HCG consistent with pregnancy (females only)
* No significant diseases or clinically significant findings in a physical examination.
* No clinically significant abnormal laboratory values.
* No clinically significant findings in vital signs measurements and a 12-lead electrocardiogram (ECG).
* Be informed of the nature of the study and given written consent prior to receiving any study procedure.
* Females who participate in this study are:

  * unable to have children (e.g. post-menopausal, tubal ligation, hysterectomy or,
  * willing to remain abstinent \[not engage in sexual intercourse\] or,
  * willing to use an effective method of double-barrier birth control \[partner using condom and female using diaphragm, contraceptive sponge, spermicide or IUD\].
* Females who participate in this study are not pregnant and/or non-lactating.

Exclusion Criteria:

* Known history or presence of any clinically significant medical condition.
* Known or suspected carcinoma.
* Known history or presence of:

  * Hypersensitivity or idiosyncratic reaction to oxcarbazepine and/or any other drug substances with similar activity.
  * Alcoholism within the last 12 months.
  * Drug dependence and/or substance abuse.
  * Use of tobacco or nicotine-containing products within the last 6 months.
* On a special diet within 4 weeks prior to drug administration (e.g. liquid, protein, raw food diet).
* Participated in another clinical trial or received and investigational product within 30 days prior to drug administration.
* Donated up to 250 mL of blood within the previous 30 days OR Donated from 251 to 500 mL of blood in the previous 45 days OR Donated more than 500 mL of blood in the previous 56 days (based on the Canadian Blood Services guideline for blood donation.
* Females taking oral or transdermal hormonal contraceptives within 14 days preceding period 1 dosing.
* Females having taken implanted or injected hormonal contraceptives within 6 months prior to period 1 dosing.
* Requirement of any medication (prescription, hormonal contraceptive and/or over-the-counter) on a routine basis, with the exception of nutritional supplements and/or occasional use of common analgesics.
* Difficulty fasting or consuming the standard meals.