cyrilzakka/clinical-trials huggingface dataset:
Combined Endoscopic Epicardial and Percutaneous Endocardial Ablation Versus Repeated Catheter Ablation in Persistent and Longstanding Persistent Atrial Fibrillation

This is a prospective, randomized (2:1) multicenter trial to investigate the optimal treatment of Persistent and Longstanding Persistent AF referred for Radiofrequency (RF) ablation.The study objective is to compare the efficacy and safety of two interventional approaches, in preventing the recurrence of AF in symptomatic, drug refractory patients with persistent or longstanding persistent atrial fibrillation.


Eligibility Criteria:
Inclusion Criteria:

1. Patient has a history of symptomatic Persistent AF and a left atrium (LA) \> 4cm or Long Standing Persistent AF as defined by the HRS/EHRA/ECAS expert consensus statement
2. Patient is refractory to or intolerant of at least one antiarrhythmic drug (class I or III)
3. Patient is mentally able and willing to give informed consent

Exclusion Criteria:

1. Patient has longstanding persistent AF \> 10 years
2. Patient presenting with paroxysmal AF
3. Patient with persistent AF and a LA-diameter ≤ 4cm
4. AF is secondary to electrolyte imbalance, thyroid disease, or other reversible or non-cardiovascular cause
5. Patient underwent previous ablation procedure or heart surgery
6. Patient needs other cardiac surgery procedures besides AF treatment (valve, coronary, others)
7. Contraindication for either catheter ablation or epicardial surgery (including, but not limited to: previous thoracic radiation, previous perimyocarditis, Previous cardiac tamponade, Pleural adhesions, Prior thoracotomy)
8. Body mass index \> 35
9. LA Diameter \> 6 cm
10. Left ventricular ejection fraction \< 30 %
11. Severe mitral regurgitation (\>II)
12. Patient unable to undergo TransEsophageal Echocardiogram (TEE)
13. Presence of LA thrombus by TEE, CT scan, MRI or angiography
14. History of cerebrovascular disease, including stroke or transient ischemic attack (TIA) within 6 months prior to enrollment
15. Active infection or sepsis
16. Other clinical conditions precluding inclusion (e.g., organ disease, disturbances of hemostasis)
17. Contraindication to anticoagulant therapy, or inability to comply with anticoagulant therapy
18. Pregnancy, planned pregnancy or breastfeeding
19. Life expectancy is less than 12 months
20. Patient is involved in another study involving an investigational drug or device
Comparison of Different Gfr Measurements in Chronic Kidney Diseases

Comparison of different Gfr measurements in Chronic Kidney Diseases

Comparison of gfr measured by different method as radionuclide method and creatinine clearance

Eligibility Criteria:
Inclusion Criteria:

* patients with proven or suspected CKD who will be referred to nuclear medicine departement of Assuit University hospital and will undergo dynamic renal imaging.

Exclusion Criteria:

* Severely ill patients
* Disturbed conscious level
* Patients on dialysis
* patients have oedema or ascites
A Study of Obinutuzumab, Rituximab, Polatuzumab Vedotin, and Venetoclax in Relapsed or Refractory Follicular Lymphoma (FL) or Diffuse Large B-Cell Lymphoma (DLBCL)

This study will evaluate the safety, efficacy, and pharmacokinetics of induction treatment with obinutuzumab, polatuzumab vedotin, and venetoclax in participants with relapsed or refractory FL, and with rituximab, polatuzumab vedotin, and venetoclax in participants with DLBCL. Participants with FL who achieve complete response (CR), partial response (PR), or stable disease (SD) at the end of induction therapy will receive post-induction treatment with obinutuzumab and venetoclax, and participants with DLBCL who achieve CR or PR at the end of induction (EOI) will receive post-induction treatment with rituximab and venetoclax.


Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
* For obinutuzumab + polatuzumab vedotin + venetoclax treatment group, relapsed or refractory FL after treatment with at least one prior chemoimmunotherapy regimen that included an anti-cluster of differentiation 20 (CD20) (anti-CD20) monoclonal antibody (mAb) and for which no other more appropriate treatment option exists, as determined by the investigator
* For rituximab + polatuzumab vedotin + venetoclax treatment group, relapsed or refractory DLBCL after treatment with at least one prior chemoimmunotherapy regimen that included an anti-CD20 mAb and for which no curative option exists as determined by the investigator
* At least one bidimensionally measurable lesion

Exclusion Criteria:

* Known CD20-negative status at relapse or progression
* Prior allogeneic stem cell transplantation (SCT), or autologous SCT within 100 days prior to Day 1 of Cycle 1
* Grade 3b FL
* History of transformation of indolent disease to DLBCL
* Current use of systemic corticosteroids greater than (\>) 20 mg prednisone per day (or equivalent); or prior anti-cancer therapy to include: radioimmunoconjugate within 12 weeks; mAb or antibody-drug conjugate within 4 weeks; or radiotherapy/chemotherapy/hormone therapy/targeted small-molecule therapy within 2 weeks prior to Day 1 of Cycle 1
* Central nervous system (CNS) disease
* Active infection
* Actual or potential cytochrome P450 (CYP) 3A interactions including: requirement for warfarin; use of strong and moderate CYP3A inhibitors or inducers within 7 days prior to first dose of venetoclax; or consumption of grapefruit, Seville oranges, or star fruit within 3 days prior to first dose of venetoclax
* Positive for human immunodeficiency virus (HIV) or hepatitis B or C
* Receipt of a live virus vaccine within 28 days prior to Day 1 of Cycle 1
* Poor hematologic, renal, or hepatic function
* Pregnant or lactating women
* Life expectancy \<3 months
Umbilical Cord Mesenchymal Stem Cell for Liver Cirrhosis Patient Caused by Hepatitis B

The study aims to evaluate the effect of allogeneic mesenchymal stem cell therapy on patients who suffered from liver cirrhosis caused by Hepatitis B.

The study is investigating the effect and safety of stem cells therapy in patients with liver cirrhosis that is specifically caused by Hepatitis B infection, the participants will be chosen based on inclusive and exclusive criteria to ensure the eligibility of the patients for this study. The patients will be given therapy in the form of allogeneic mesenchymal stem cells transplantation, the stem cells in this study were provided from Prodia Stem Cell Indonesia (ProSTEM). The stem cells being will also be subjected to certain criteria to ensure the utmost safety. The data of this study will be derived from the observation results of the patients' liver damage status in weeks 4, 6 and 12. Aside from that, hemodynamic will be conducted as a part of the observation

Eligibility Criteria:
Inclusion Criteria:

* Patients with decompensated cirrhosis (Child-Pugh B) caused by hepatitis B infection (Cirrhosis is evidenced by the results of ultrasonography examination and chronic hepatitis B infection is found in patients who are taking hepatitis B drugs)

Exclusion Criteria:

* Patients who refuse to participate in research
* Having malignancies disease, both liver malignancies or other malignancies
* Having another co-infections such as hepatitis C and Human Immunodeficiency Virus (HIV).
* Pregnant or lactation patients as evidenced by positive pregnancy test results
* Having complications disease such as diabetes mellitus, severe heart disease, kidney disease, and respiratory disease
* Having the case of alcohol dependence and NASH
* Patients who have undergone transplantation and other stem cell therapy
Adjuvant Cerebroprotection Using Normobaric Hyperoxia in Pre-hospital Patients with Suspected Stroke

The primary objective of this study is to determine the efficacy and safety of inhaled normobaric hyperoxia therapy (NBO) beginning in the pre-hospital setting in patients with suspected acute cerebral ischemia (ACI) due to large vessel occlusion presenting within 6 hours of symptom onset.

Stroke is a leading cause of death and disability globally, with acute ischemic stroke (AIS) patients often benefiting from intravenous thrombolysis and endovascular therapies such as mechanical thrombectomy, which have been shown to improve reperfusion rates. However, despite reperfusion, the proportion of patients with large vessel occlusion achieving a favorable functional outcome, defined as a modified Rankin Scale score of 0-2 at 90 days, remains under 50%.

Normobaric hyperoxia (NBO) emerges as a compelling option for cerebral protection. Its neuroprotective mechanisms are thought to include hypoxic tissue rescue, blood-brain barrier preservation, brain edema reduction, neuroinflammation alleviation, mitochondrial function improvement, oxidative stress mitigation, and apoptosis inhibition. NBO's diffusion properties allow it to reach the penumbra before reperfusion, enhancing aerobic metabolism and potentially reducing infarct volume. Its advantages also include low cost, wide availability, and ease of use, making it accessible across various healthcare settings.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 80 years old;
* Signs and symptoms are consistent with a new acute stroke, with low possibility of stroke mimics (e.g., no sudden coma, prior seizure disorder, suspected hypoglycemia);
* No prior stroke;
* The time from stroke onset/last seen well to randomization is within 6 hours;
* Paramedic-obtained FAST-ED score \>= 3 (The enrollment of patients with a FAST-ED score of 3 is prespecified to constitute no more than 10% of the total study population);
* No significant pre-stroke disability (pre-stroke mRS 0-1);
* Signed informed consent from the patient or the legally authorized representative (LAR).

Exclusion Criteria:

* Endotracheal intubation in the field (prior to consent);
* Respiratory rate \<= 10 or \>= 30 breaths per minute;
* Oxygen-dependence at baseline to maintain SaO2 \> 95%;
* Known history of severe chronic obstructive pulmonary disease (FEV1 less than 1.0), New York Heart Association (NYHA) Heart Failure Class III, acute pulmonary infection or aspiration pneumonia, prior to enrollment;
* Seizure at stroke onset;
* Exhibiting symptoms of vomiting, severe headache, or unconscious;
* Known pregnancy: women of childbearing age (18 to 44 years old according to the CDC's Division of Reproductive Health) will be asked about their pregnancy status.
* Participating in another clinical trial, or completed participation within prior 30 days;
* Receiving other neuroprotective agent (e.g., edaravone dexborneol, n-butylphthalide);
* Life expectancy \< 90 days due to comorbidities;
* Unlikely to complete the 90-day follow-up visit.
Olorinab in Irritable Bowel Syndrome With Predominant Constipation (IBS-C) and Irritable Bowel Syndrome With Predominant Diarrhea (IBS-D)

The purpose of this study is to determine whether olorinab is a safe and effective treatment for abdominal pain in participants with irritable bowel syndrome (IBS).


Eligibility Criteria:
Main Study Inclusion Criteria:

* Diagnosis of irritable bowel syndrome (IBS) with predominant constipation (IBS-C) or predominant diarrhea (IBS-D) according to Rome IV criteria at Visit 1 (Screening)
* Per the Rome IV diagnostic algorithm for IBS, participants 50 years of age and over are to have had one of the following with a result that rules out causes of abdominal pain other than IBS:

  1. Colonoscopy (within 10 years of Visit 1 \[Screening\])
  2. Flexible sigmoidoscopy and double contrast barium enema (within 5 years of Visit 1 \[Screening\])
  3. Computed tomography colonography (within 5 years of Visit 1 \[Screening\])

Main Study Exclusion Criteria:

* Diagnosis of IBS with mixed bowel habits (IBS-M) or unsubtyped IBS (IBS-U)
* Clinically relevant changes in dietary, lifestyle, or exercise regimen within 30 days prior to Visit 1 (Screening) that may confound efficacy assessments in the clinical judgment of the Investigator (or designee)
* Any colonic or major abdominal surgery (eg, bariatric surgery \[including gastric banding\], stomach surgery, small/large bowel surgery, or abdominal large vessel surgery). History of cholecystectomy is exclusionary for participants with IBS-D. For participants with IBS-C, a history of cholecystectomy more than 6 months prior to Visit 1 (Screening) is allowed. Procedures such as appendectomy, hysterectomy, caesarean section, or polypectomy are allowed as long as they have occurred at least 3 months prior to Visit 1 (Screening).

Long-Term Extension Inclusion Criteria:

•All participants must have completed the Main Study (including both Visit 8 \[Week 12\] and Visit 9 \[Week 14\])

Long-Term Extension Exclusion Criteria:

* Participant meets any exclusion criteria from the Main Study at the time of assessing eligibility for the LTE, unless approved by the Sponsor in advance.
* Participant had less than 75% overall compliance with eDiary entries during the Main Study.
* Participant deviated from the prescribed dosage regimen during the Main Study (ie, overall study treatment compliance less than 85% or more than 115%), unless approved by the Sponsor in advance.
Efficacy and Safety Study of Subcutaneous Secukinumab in Treatment of Subjects With Moderate to Severe Chronic Plaque-type Psoriasis as Compared to Etanercept and Placebo.

This withdrawn study was to assess the safety and efficacy of secukinumab compared to etanercept and placebo in patients who have moderate to severe, chronic, plaque-type psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* Chronic plaque-type psoriasis, moderate to severe
* Candidate for systemic therapy defined as having psoriasis not adequately controlled by: topical treatment, phototherapy and/or previous systemic therapy

Exclusion Criteria:

* Forms of psoriasis other than chronic plaque-type
* Ongoing use of treatments not allowed for psoriasis

Other protocol-defined inclusion/exclusion criteria may apply
Evaluation of a New Therapeutic Strategy in Early and Active Relapsing-Remitting Multiple Sclerosis

The aim of the study is to determine whether a therapeutic strategy combining mitoxantrone and interferon beta1b can delay disease progression of at least one point on EDSS scale in patients with clinically very active relapsing-remitting multiple sclerosis.


Eligibility Criteria:
Inclusion Criteria:

* age : 18-45 years,
* Clinical disease satisfying the Poser criteria (Amdmt n°4)
* relapsing-remitting disease (Amdmt N°4)
* at least 2 exacerbations within the preceding 12 months, having left sequelae,
* MRI activity at inclusion expressed by at least one gadolinium-enhanced lesion (cranial MRI with 0.1mmol/kg gadolinium),
* a significant disability at inclusion: EDSS score between 2.5 and 5.5 (Amdt N° 4)
* written informed consent

Exclusion Criteria:

* pregnancy and breast-feeding
* use of an insufficiency effective contraceptive method,
* general immunosuppressive therapy using cyclophosphamide, mitoxantrone,or total lymphoid irradiation
* treatment with azathioprine during the 3 months preceding the study
* clinical relapse or intensive corticosteroid treatment within the 30 days preceding inclusion,
* associated disease (psychiatric disorder, depressive statenot controlled by appropriate drug therapy, history of heart disease at inclusion examination
African American Cancer Clinical Trial Decisions: Testing Tailored Messages

The purpose of this study is to determine if the use of tailored health messages and/or involving physicians are effective in increasing African American (AA) patient activation in a clinical trial consultation. The proposal will use a composite score for patient activation derived from the Street Patient Activation Coding system. This will help to determine the effectiveness of our intervention on patient activation and patient centered clinical trial decision.

A randomized clinical trial (using a 2x2 factorial design) to inform our knowledge of the efficacy of a tailored health message intervention, using different depths of tailoring and involving physicians, on AA cancer patients' active communication in CT consultations as measured by the Street Patient Activation measure. In this study 357 AA cancer patients will be randomized into one of four experimental groups Group 1 - messages tailored on Electronic Medical Record (EMR) data. Group 2 - messages tailored on EMR + physician involvement. Group 3 - messages tailored on EMR + survey. Group 4 - Messages tailored on EMR + survey + physician involvement. We will also measure patient: a) trust in their physician, b) trust in medical research, c) preferences that include information and decision involvement, d) communication self-efficacy, e) patient-family member communication congruence, f) consultation satisfaction and g) decision outcomes that include decisional conflict, decision satisfaction and decision regret.

Eligibility Criteria:
Inclusion Criteria:

* 21 years of age or older
* Have a cancer diagnosis
* Self identify as African American
* Therapeutic Phase I, II or III clinical trial at Massey Cancer Center (regardless of whether or not they join the therapeutic trial)
* Be able to provide informed consent
* We will also recruit one family member/caregiver (N = 357) of each participating patient
* Consented patients will not be excluded from this study if their family member declines to participate by completing the Cancer Communication Assessment Tool for Families (CCAT-F).

Exclusions Criteria:

-None
Functional and Clinical Outcomes of Hyaluronic Acid and Steroid Injections in Bilateral Knee Osteoarthritis

The aim of this study is to compare functional and clinical outcomes of intraarticular injections of hyaluronic acid and steroids in patients with bilateral knee osteoarthritis. We will compare clinical and functional outcomes for each knee separately after week 6, month 3, month 6, and one year after the intervention.

We will include patients with bilateral knee osteoarthritis (Kellgren Lawrence grades 2 and 3). On initial examination, we will measure active and passive range of flexion and extension, presence of swelling, joint effusion, VAS score for each knee separately, and WOMAC score for every knee separately. We will randomly apply hyaluronic acid injection in one knee and steroid injection in the other knee. We will repeat the same examination after week 6, month 3, month 6, and one year after the procedure. The main aim is to check whether there is a significant clinical or functional difference between two groups.

Eligibility Criteria:
Inclusion Criteria:

* bilateral knee pain
* same grade of osteoarthritis in both knees
* Kellgren-Lawrence grade 2 or 3 of knee osteoarthritis
* fully completed all follow-up examinations

Exclusion Criteria:

* unilateral knee osteoarthritis
* different grade of osteoarthritis between knees based on Kellgren-Lawrence scale
* positive history of previous knee interventions (injections, surgery)
* positive history of additional knee injuries (meniscus, ligament...)
NFC Changes in SLE Patients and Its Correlation With Anti-U1RNPAntibodies and Disease Activity

1. Detection of different pattern of nail fold capillary changes in SLE patient.
2. Correlation of nail fold capillary changes in SLE patients and Anti-U1RNP antibodies.
3. Correlation of nail fold capillary changes with SLE disease activity.
4. Frequency of nail fold capillary changes in SLE patients

Systemic lupus erythematosus is a complex, multi-organ autoimmune disease . The presence of autoantibodies and circulating immune complexes can cause vasculitis and damage the endothelial cells, leading to multiple organ dysfunctions .The clinical manifestations of SLE include muco cutaneous, musculoskeletal system, cardiac, neurological, renal, hematologic, and vascular system involvement . Nail fold capillaroscopy (NFC) is a non-invasive easily repeatable technique and the best method for morphological analysis of nutritional capillaries in the nail fold area . Nail fold capillary changes are very common in patients with SLE. the major NFC pattern that has been reported in SLE patients was non-specific sub-types, followed by normal pattern and scleroderma pattern. In (SLE) patients are reported a large spectrum of antibodies, including the anti-ribonucleoproteins (RNP) antibodies These antibodies were linked to several clinical manifestations and prognostic in patients with SLE. Anti-U1-RNP antibodies are involved in both innate and adaptive immune responses during pathogenesis of connective tissue diseases 12. U1-RNP complex is an intra nuclear protein that converts pre-mRNA to mature RNA and constitutes three specific proteins A, C, and 70 kDa. High titer RNP antibodies are detected in MCTD patients and correlated with Clinical disease activity index and the frequent complication of pulmonary artery hypertension in those patients . It also has been found that NFC may detect subclinical microvascular changes in SLE in the presence of anti-U1-RNP antibodies and may facilitate early preventive therapy for major organ vasculopathy .

Eligibility Criteria:
Inclusion Criteria:

* Adult SLE Patients who fulfilled the 2012 systemic lupus international collaborating clinics (SLICC) criteria

Exclusion Criteria:

1. SLE patient aged less than 18 yeares old.
2. Individuals with other autoimmune diseases (rheumatoid arthritis dermatomyositis, scleroderma, mixed connective tissue disease).
3. Congestive cardic failure and presence of clupping.
4. Coexisting diabetes mellitus.
5. history of smoking.
6. Patients unable to co-operate for nailfold capillaroscopic examination
Diagnostic Accuracy Study of Indocyanine Green for Perfusion Assessment

Background Near-infrared fluorescence guided surgery with indocyanine green (ICG) was introduced for parathyroid perfusion assessment during total thyroidectomy in 2016. ICG can visualize tissue perfusion, since it becomes completely and permanently fixed to plasma proteins in the bloodstream, and circulates in the intravascular compartment only. ICG was already approved in 1956 for clinical use of tissue perfusion. However, until now there is still no (parathyroid) universal standard imaging protocol for ICG-guided fluorescent surgery including quantitative evaluation.

Main research question To develop a standardized universal imaging protocol for the assessment of parathyroid perfusion during total thyroidectomy with ICG including quantitative evaluation of the fluorescent signal.

• Design (including population, confounders/outcomes) This will be a proof-of-concept, prospective cohort study of patients undergoing an ICG-guided fluorescent total thyroidectomy to evaluate parathyroid gland perfusion. The main study endpoint is quantification of the fluorescent signal of ICG stratified by the occurrence of hypoparathyroidism. Hypoparathyroidism will be defined as a decrease in PTH of \&gt;70% at the first postoperative day. Furthermore, we will calculate the sensitivity of our model for the prediction of hypoparathyroidism.

Secondary outcomes are data from surgery, pre- and postoperative lab values (including calcium, PTH, albumin) and postoperative medication use.

Expected results We expect that the results of this study will lead to the development of a universal standard imaging protocol for ICG-guided fluorescent total thyroidectomy.


Eligibility Criteria:
Inclusion Criteria:

1. Age \&gt;18 years
2. Patients undergoing ICG-guided total thyroidectomy as surgical procedure for thyroid cancer, Graves' disease or goiter
3. Patients are eligible for surgery
4. Patients are mentally competent
5. Written informed consent

Exclusion Criteria:

1. Patients with known allergy for ICG or iodinated contrast
2. Pregnant or lactating women
3. Patients with previous neck surgery
4. Patients with dialysis dependent renal failure and kidney transplant