cyrilzakka/clinical-trials huggingface dataset:
Long-Term Evaluation of TAILORED Vs Anatomical Ablation Strategy for Persistent Atrial Fibrillation

The TAILORED-LT study is conducted as an extension follow-up until 5 years of the initial TAILORED-AF study (NCT04702451), in order to demonstrate the long-term superiority in terms of freedom of atrial fibrillation (AF) of a tailored ablation strategy targeting areas of spatio-temporal dispersed electrograms in combination with pulmonary veins isolation (PVI) over an anatomical ablation strategy targeting PVI alone for the initial ablation procedure of persistent AF.

The TAILORED-AF study demonstrated at one year's follow-up that a tailored ablation strategy guided by Volta Medical AI-software targeting areas of spatio-temporal dispersed electrograms in combination with pulmonary vein isolation (PVI) ablation is more effective to an anatomical ablation strategy targeting PVI alone (current standard of care) for the treatment of persistent atrial fibrillation (AF).

VX1 legacy device renamed Volta AF-Xplorer was used in the TAILORED-AF study in the treatment arm.

No additional treatments are specifically required in the scope of this ancillary TAILORED-LT study which aims to follow the patients previously treated in the initial TAILORED-AF study over the long-term. However, in the event of repeat procedures during the TAILORED-LT study, the choice of the ablation technique will be left to the investigator's discretion, regardless of the patient's randomization arm in the TAILORED-AF study.

The annual follow-up will be performed as in routine clinical practice post AF ablation procedures: visits at 24 months, 36 months, 48 months and 60 months post TAILORED-AF Study index procedure. It is possible that some of these annual visits cannot be completed prospectively due to time already having elapsed between the end of the subject participation in the TAILORED-AF study and the date of enrollment in the extension TAILORED-LT study. In this case, available data (among those expected by the study protocol) will be collected retrospectively.

The additional procedures related to this clinical investigation are limited to annual 24-hour Holters and to the administration of Quality Of Life questionnaires (SF-36 and AFEQT) to the patients during follow-up visits.

Eligibility Criteria:
Inclusion Criteria:

* Patient who participated in the Tailored AF study
* Patient not withdrawn during the 12-month follow-up period post-index procedure in the Tailored AF study
* Patient able and willing to provide written informed consent to participate in this extension Tailored-LT study

Exclusion Criteria:

* Person deprived of liberty or under guardianship
* Person unable to undergo a medical monitoring for geographical, social or psychological reasons
Role of Endothelial Function, Muscular Fitness and Metabolism in Functional Activity in Patients With Chronic Heart Failure (CHF)

Shortness of breath, fatigue, and exercise intolerance are clinical symptoms of chronic heart failure (CHF). Recent studies suggested that peripheral impairment was the major cause of clinical symptoms, and mechanism may be related to neuroendocrine impairment and vascular smooth muscle dysfunction. It results in increased peripheral resistance that may influence limb blood flow, muscle fitness and activities of daily.The purposes of this study are

1. to compare muscular strength, endurance, and perfusion of quadriceps between CHF patients and healthy controls by isokinetic test and near-infrared spectroscopy (NIRS) and difference in activities of daily living
2. to compare endothelium function between CHF patients and healthy control subjects
3. the relationship between endothelium function, muscular strength, endurance, perfusion, and metabolism of quadriceps.


Eligibility Criteria:
Inclusion Criteria:

* Age 40-75 years
* Chronic heart failure: ejection fraction\<40% and at stable condition
* Coronary Disease and dilated cardiomyopathy without heart failure
* Control group without diagnosis of any heart disease

Exclusion Criteria:

* Clinical diagnosis of neuromusculoskeletal , pulmonary, or other systemic diseases that may affect the testing of the study
A Study to Evaluate Mezigdomide in Combination With Carfilzomib and Dexamethasone (MeziKD) Versus Carfilzomib and Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma (SUCCESSOR-2)

The purpose of the study is to compare Mezigdomide (CC-92480/BMS-986348) with carfilzomib and dexamethasone (MeziKD) against carfilzomib and dexamethasone (Kd) in the treatment of RRMM: SUCCESSOR-2.


Eligibility Criteria:
Inclusion Criteria

- Participant has documented diagnosis of multiple myeloma and measurable disease, defined as any of the following:.

i) Myeloma-protein (M-protein) ≥ 0.5 grams/deciliter (g/dL) by serum protein electrophoresis (sPEP), or.

ii) M-protein ≥ 200 milligrams (mg)/24-hour urine collection by urine protein electrophoresis (uPEP) or,.

iii) For participants without measurable disease in sPEP or uPEP: serum free light chain levels \> 100 mg/liter (L) (10 mg/dL) involved light chain and an abnormal κ/λ free light chain ratio.

* Participant has received at least one prior line of anti-myeloma therapy. Note: One line can contain several phases (e.g., induction, \[with or without\] hematopoietic stem cell transplant, (with or without) consolidation, and/or \[with or without\] maintenance therapy).
* Participant must have received prior treatment with lenalidomide and at least 2 cycles of an anti-CD38 monoclonal antibody (mAb) (participants who were intolerant of an anti-CD38 mAb and received \< 2 cycles are still eligible).
* Participant achieved minimal response or better to at least 1 prior anti-myeloma therapy.
* Participant must have documented disease progression during or after their last antimyeloma regimen.

Exclusion Criteria

* Participant who has had prior treatment with mezigdomide or carfilzomib.
* Participant has previously received allogeneic stem cell transplant at any time or received autologous stem cell transplant within 12 weeks of initiating study treatment.
* Other protocol-defined Inclusion/Exclusion criteria apply.
The LEADLESS Observational Study

The objective of the study is to confirm clinical performance and safety of the Nanostim leadless cardiac pacemaker system within its intended use and according to its instructions for use.


Eligibility Criteria:
Inclusion Criteria:

* Subject must have one of the following clinical indications: Chronic atrial fibrillation with 2 or 3° AV or bifascicular bundle branch block (BBB block) ; or Normal sinus rhythm with 2º or 3° AV or BBB block and a low level of physical activity or short expected lifespan (but at least one year); or Sinus bradycardia with infrequent pauses or unexplained syncope with EP findings; and
* Subject ≥18 years of age; and
* Subject has life expectancy of at least one year and is a suitable candidate based on overall health and well-being; and
* Subject is not enrolled in another clinical investigation with a treatment arm or that could confound the results of this study; and
* Subject is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams; and
* Subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by the EC; and
* Subject is not pregnant and does not plan on getting pregnant during the course of the study.

Exclusion Criteria:

* Known pacemaker syndrome, have retrograde VA conduction or suffer a drop in arterial blood pressure with the onset of ventricular pacing; or
* Hypersensitivity to \< 1 mg of dexamethasone sodium phosphate; or
* Mechanical tricuspid valve prosthesis; or
* Pre-existing pulmonary arterial (PA) hypertension (PA systolic pressure exceeds 40mmHg or RV systolic pressure (RVSP) as estimated by echo exceeds 40mmHg) or significant physiologically-impairing lung disease (has severe pulmonary disease producing frequent hospitalization for respiratory distress or requiring continuous home oxygen); or
* Pre-existing ventricular pacing or defibrillation leads; or
* Current implantation of either conventional or subcutaneous implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT); or
* Presence of implanted vena cava filter; or
* Evidence of thrombosis in one of the veins used for access during the procedure; or
* Cardiovascular or peripheral vascular surgery/intervention within 30 days of enrolment; or
* Presence of implanted leadless cardiac pacemaker
Efficacy of Moxibustion Therapy With or Without Smoke for Knee Osteoarthritis

This is a multicentre, randomised, single blinded, parallel-group design clinical trial to assess the effect of moxa smoke in the treatment using moxibustion for Knee Osteoarthritis.

Aim: To assess the effect of moxa smoke in the treatment using moxibustion for knee osteoarthritis.

Design: This is a multicentre, randomised, single blinded, parallel-group design clinical trial. 138 eligible participants will be randomly allocated into 2 groups (moxibustion group or smoke-free moxibustion group) with a 1:1 allocation ratio, and receive 12 sessions of moxibustion treatment over a period of 4 weeks, three sessions per week. Each session will last 30 minutes. The whole study period is 13 weeks, with a 1 week run in period, 4 week treatment phase, and 8 week follow-up phase.The participants will receive moxibustion treatment at three acupoints (EX-LE04,ST35,ST36). In moxa-free smoke moxibustion group, investigators place a purification device(Shenzhen Conyson Electronic Technology Co, Ltd,C200 moxa smoke purification device,Shenzhen,China) at the top of the moxibustion to remove the moxa smoke. The primary measurement outcomes are the mean change in the global scale value of the Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) pain and function scores from baseline to 4 weeks. The secondary outcomes are the Visual Analogue Scale (VAS) and the patient global assessment. Investigators will assess participants at the second visit (before starting moxibustion treatment) and at the 2, 4, 8, and 12 week respectively after the baseline.

Eligibility Criteria:
Inclusion Criteria:

Participants meeting the following criteria will be included:

1. aged between 40 and 75 years
2. diagnosed with knee osteoarthritis formulated by the American College of Rheumatology (ACR).
3. the average severity of knee pain not more than 7 points on a visual analogue scale for most days during the past month
4. agree not have the paregoric during the whole treatment phase
5. willingness to participate in a randomized study and to sign the informed consent form.

Exclusion Criteria:

Participants will be excluded if they have these experiences:

1. inflammatory diseases, including rheumatoid arthritis, cancer, traumatic injury that might be related to the current knee pai
2. autoimmune disease, uncontrolled hypertension
3. diabetes mellitus requiring insulin injection
4. life-threatening cardiovascular or neurological events within the past year
5. chronic respiratory disease,a haemorrhagic disorder
6. alcohol or drug addiction
7. an active infectious disease including tuberculosis
8. a significant knee joint deformity
9. knee replacement surgery for the affected knee
10. knee arthroscopy within the past year
11. steroid injection in the knee joints within the past 3 months
12. injections in the knee joints or joint fluid injection within the past 6 months
13. accept acupuncture, moxibustion, cupping, or herbal medicine within the past 4 weeks
Switch From Calcineurin Inhibitor to Belatacept in Pancreas Transplant Recipients

Kidney damage is a major complication of current antirejection medicines used in transplantation. An increasing number of brittle diabetics are successfully receiving a pancreas transplant. One of the challenges following pancreas transplant is that a patient can develop kidney damage from one of their antirejection medicines, tacrolimus. The objective of this study is to substitute a new antirejection medicine which does not cause kidney damage, belatacept for tacrolimus in patients that have developed signs of tacrolimus related kidney damage to slow the progression of kidney disease.

Nephrotoxicity is a major complication of current immunosuppression regimens used in transplantation. Pancreas transplantation has been increasedly performed to manage labile diabetes mellitus during the last few decades and survival rates of pancreatic grafts are improving. One of the challenges that is faced following pancreas transplantation alone are pathologic changes from diabetes frequently seen in native kidneys in the pancreas transplant recipients. High levels of calcineurin inhibitors (CNI) have been identified as risk factors for decline in kidney function and progression to end-stage renal disease. The objective of this trial is to take subjects who have biopsy proven CNI toxicity off of their CNI and begin belatacept, which is not a CNI.

The hypothesis is by switching the pancreas transplant subject with documented CNI kidney toxicity to belatacept will slow the progression of chronic kidney disease.

Eligibility Criteria:
Inclusion Criteria:

* Pancreas transplant alone recipients
* EBV IgG positive
* Biopsy proven calcineurin inhibitor toxicity on native kidney biopsy
* Maintained on a regimen of tacrolimus, sirolimus, mycophenolate

Exclusion Criteria:

* EBV IgG negative
* Not maintained on an immunosuppression regimen that contains tacrolimus
* Unable or unwilling to give informed consent
* Active infection
* History of malignancy post transplant
* Glomerular filtration rate \< 15 mL/min
Evaluation of Immunological Reconstitution After Haploidentical Bone Marrow Transplantation

Evaluation of immunological reconstitution after haploidentical BMT using a nonmyeloablative preparative regimen and post-transplant cyclophosphamide in patients with poor prognosis lymphoma


Eligibility Criteria:
Inclusion Criteria:

* Patients with lymphoma (any histology) relapsed after high dose chemotherapy and in partial remission, complete remission or stable disease after the last CT line that
* Signed informed consent to perform an haploidentical allo-BMT using a nonmyeloablative preparative regimen and post-transplant cyclophosphamide

Exclusion Criteria:

none
A Study to Assess the Effect and Safety of AZD6765 in Patients With Major Depressive Disorder

The purpose of this study is to assess the effect and safety of AZD6765 in patients with major depressive disorder who exhibit inadequate response to antidepressants. AZD6765 is a channel blocker of the N-methyl-D-aspartate (NMDA) class of glutamate receptors.

A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase IIb Efficacy and Safety Study of Adjunctive AZD6765 in Patients with Major Depressive Disorder (MDD) and a History of Inadequate Response to Antidepressants

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent before initiation of any study-related procedures.
* Male or female patients aged 18 to 70 years, inclusive.
* The patient must have a clinical diagnosis of major depressive disorder with a lifetime history of inadequate response to at least 3 antidepressants.
* Women of child-bearing potential must have a negative serum pregnancy test and confirmed use of a highly effective form of birth control before enrollment for a minimum of 3 months before study start.
* Outpatient status at screening and randomization visits.

Exclusion Criteria:

* Patients with a history of diagnosed bipolar disorder or schizophrenia or schizoaffective disorder or currently exhibiting psychotic features associated with their depression; dementia or suspicion thereof.
* Patients who have had a suicide attempt within the last 6 months.
* Electroconvulsive therapy (ECT), vagal nerve stimulation (VNS) or transcranial magnetic stimulation (TMS) or previous treatment with ketamine infusion within the 6 months prior to screening, or any history of deep brain stimulation.
* Patients with any history of seizure disorder (except for febrile seizures in childhood).
* Pregnancy or lactation.
Correlation Between Urine UACR and Postoperative Neurocognitive Disorder in Elderly Patients With Non-cardiac Surgery

This study intends to evaluate the relationship between urinary albumin/creatinine ratio and postoperative neurocognitive impairment in elderly non-cardiac surgery patients. The results of the study are to identify risk factors, screen high-risk populations to improve clinical evidence, early detection and early treatment.And reducing the burden of PNCD on patients and their families, hospitals and public resources.


Eligibility Criteria:
Inclusion Criteria:

* Non-cardiac surgery patients;

  * Age is greater than or equal to 60 years old; ③Han Nationality, mother tongue is chinese;

    ④The MMSE score:Illiteracy is greater than or equal to 17 points, primary school is greater than or equal to 20 points, higher secondary school is more than 24 points;

    ⑤The people signed informed consent.

Exclusion Criteria:

* The diagnosis of preoperative delirium；

  * The diagnosis Unstable hypertension（Such as：pheochromocytoma or aortic dissection）； ③Severe chronic obstructive pulmonary disease or congestive heart failure； ④Severe liver and kidney dysfunction;
Treatment of Knee Pain With Topical Diclofenac Cream 8% or Diclofenac Gel 1%

Non-steroidal anti-inflammatory medication (NSAID) therapy is a mainstay treatment for joint pain and painful musculoskeletal disorders. Though this form of systemic therapy is highly effective, it causes substantial side effects including gastritis and gastric ulcer disease, renal impairment, hypertension, and thrombotic events. These types of oral medications are utilized by millions of Americans on a fairly regular basis in both over-the-counter preparations and prescription compounds. In recent years, topical preparations of NSAIDs have been used for localized pain as an alternate to oral administration with reported good analgesic efficacy. For example, they are often used for knee pain. There is little systemic absorption of NSAIDs with topical administration, and consequently less likelihood of systemic side effects.

Though much less studied than oral NSAIDs, topical NSAID preparations are currently prescribed for a variety of arthritic and musculoskeletal types of pain. The best-studied commercially available products are diclofenac 1% compounds. Higher concentrations presumably provide higher tissue concentration leading to better and longer pain relief, along with a more prominent anti-inflammatory effect.

The investigators will therefore compare the efficacy of available topical diclofenac 1% gel to that of diclofenac 8% cream. Specifically, the investigators propose to test the hypothesis that efficacy of topical diclofenac 8% exceeds that of diclofenac 1%, without any increase in systemic toxicity.

One hundred six patients presenting to the Cleveland Clinic Pain Management Department for the treatment of knee pain will be randomly assigned to topical diclofenac cream 8% or diclofenac gel 1%, with the designated medication applied the symptomatic area of the knee over 6 weeks. Investigators will be blinded to treatment, and will evaluate pain relief and functional/disability status.


Eligibility Criteria:
Inclusion Criteria:

* Acute and chronic knee pain, along with postoperative knee pain lasting at least two months.

Exclusion Criteria:

* Patients will be excluded if deemed inappropriate for application of topical medication therapy by the treating physician. This will include adult patients with diffuse (non-localized) pain disorders and those likely to need knee surgery during the treatment period.
* Patients with knee infection, open knee wounds, or acute knee skin lesions will be excluded.
* Patients with diclofenac or wheat or gluten allergies will also be excluded.
Patient Ambassador

The overall objective of this study is to design and evaluate a peer ambassador intervention to improve gynecologic cancer trial enrollment. The primary Aim is to determine the possibility of using peer ambassadors to increase discussion, awareness, and enrollment of patients with advanced or recurrent gynecologic cancer onto clinical trials.

Participants will participate in a peer ambassador program where a patient ambassador (mentor) will be paired with a mentee. The patient ambassador will be a patient with history of gynecologic cancer who has experience with clinical trials and can serve as an ambassador to facilitate discussions regarding education and awareness of clinical trials. This discussion will potentially assist mentees to make informed decisions about their engagement in discussing clinical trials, looking for clinical trials, and desire and acceptance of clinical trials. This will also allow ambassadors to gain information about perceived barriers regarding clinical trials.

The investigators seek to identify patient ambassadors, who will be trained to lead 1:1 discussion with patient mentees. Each ambassador will be paired with up to 5 mentees. Each ambassador-mentee pairing will have 1-2 encounters (meetings) over the course of 12 months. The total number of encounters and the total number of ambassador-mentee dyads created, will be logged.

Enrollment and study visits will occur over a 12 month period. Each mentor will be in the study approximately one year, and each mentee will be in the study approximately 2 months.

Eligibility Criteria:
Mentee Inclusion Criteria:

* Eligible subjects will include those with advanced gynecologic cancer (metastatic or persistent/progressive disease despite primary treatment) or high-risk gynecologic cancer undergoing active systemic therapy not currently enrolled on clinical trials. These patients include those starting a new line of chemotherapy, or who have a diagnosis needing chemotherapy.
* Patients will be identified from the UPHS gynecologic oncology and medical oncology clinics serving gynecologic cancer patients (Penn Medicine Washington Square, PCAM/HUP, Radnor, Chester County, Penn Medicine Cherry Hill). Clinic rosters over 6 months intervals will be screened for eligibility.
* Patients who have been discussed at tumor board conferences and recommended to consider clinical trials will screened for recruitment.

Exclusion Criteria:

* N/A
Efficacy and Safety of Dapagliflozin in Children With Proteinuria

The purpose of the study is to investigate the antiproteinuric effect of Dapagliflozin in children with proteinuria.


Eligibility Criteria:
Inclusion Criteria:

* Age 6 years to 18 years;
* Urinary protein excretion \> 0.2g in a 24-hr urine collection;
* eGFR≥60 ml/min/1.73m2;
* No history of diabetes;
* On stable doses of ACE inhibitors or angiotensin receptor blockers (ARBs) for \> 1 month;

Exclusion Criteria:

* Receiving immunosuppressive therapy within three months prior to enrolment.
* Blood pressure less than 5th percentile of the same gender, age, and height -
* Leukocyte and/or nitrite positive urinalysis that is untreated;
* History of organ transplantation, cancer, liver disease;
* Evidence of hepatic disease as determined by any one of the following: ALT or AST values exceeding 3x ULN at the screening visit;
* History of noncompliance to medical regimens or unwillingness to comply with the study protocol.