cyrilzakka/clinical-trials huggingface dataset:
Ganglionated Plexi Ablation Combined With Pulmonary Vein Isolation

The investigators have conducted a prospective, double-blind, randomized study to assess the comparative safety and efficacy of two different ablation strategies, PVI plus linear lesions (LL) versus PVI plus GP ablation, in patients with persistent or longstanding persistent AF. Results were assessed after follow-up of at least 3 years with the use of an implanted monitoring device (IMD).


Eligibility Criteria:
Inclusion Criteria:

* Persistent and longstanding persistent AF

Exclusion Criteria:

* congestive heart failure
* LV ejection fraction \< 35%
* left atrial diameter \> 60 mm
Taurine Supplementation on Lower Extremity Vasculopathy in Patients With Diabetes

Diabetes has become important risk factors for threatening human life and health. Lower extremity arterial occlusive are the common complications of diabetes.Sulfur amino acid is the indispensable amino acid in mammals, and its metabolites include Taurine, Hydrogen sulfide (H2S) and sulfur dioxide (SO2). Taurine was first isolated more than 150 years ago from ox (Taurus) bile. Although the taurine can be synthesized in vivo by cysteine in the presence of cysteine dioxygenase, it is mainly acquired from dietary sources, such as eggs, meat, and seafood. H2S is a biologically relevant mediator and plays potential roles in several physiological processes and disease states in the body. H2S is synthesized from 2 sulfur-containing amino acids, l-cysteine andl-methionine, by the 3 enzymes,cystathionine-γ-lyase (CSE), cystathionine-β-synthetase(CBS), and3-mercaptopyruvate sulfurtransferase (3-MST). Previous studies have demonstrated that Taurine and H2S may play important roles in the development of the microangiopathy and lower extremity arterial occlusive.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, age between 18-80 years old
2. Type 2 diabetes

Exclusion Criteria:

1. Type2 diabetes with acute diabetic complications.
2. Type1 diabetes.
3. History of cardio-cerebral vascular events, such as congestive heart failure, myocardial infarction or stroke within 3 months.
4. Hypohepatia (AST or AST is twice higher than the upper limit) or history of hepatitis or cirrhosis, hepatic encephalopathy.
5. Renal insufficiency (serum creatinine 1.5 times higher than the upper limit) or history of dialysis and nephritic syndrome.
6. Acute infections, tumor, severe arrhythmia, mental disorders, alcohol or medicine addiction.
7. Fertile woman without contraceptives.
8. Any surgical or medical conditions that significantly influence absorption, distribution, metabolism or excretion of the intervention drugs.
9. Allergic to or have contraindication to the intervention drugs.
SGLT2 Inhibitors in Patients With PCOS

Polycystic ovary syndrome (PCOS) is a common endocrine disorder, with a prevalence of 5% to 15% in premenopausal women. Patients with PCOS presents as abnormal menstruation, ovulation disorders and/or hyperandrogenemia, and often accompanied by insulin resistance and other metabolic abnormalities. Metformin has been clarified as an option in patients with PCOS. However, the clinical responses to metformin are limited and different. Sodium glucose co-transporter 2 (SGLT2) inhibitors are novel drugs for the treatment of type 2 diabetes, with weight loss, reducing insulin resistance and cardiovascular benefits. Limited data is available on the efficacy of SGLT2 inhibitors in patients with PCOS.

This clinical study aims to determine the safety and efficacy of canagliflozin vs metformin in Polycystic Ovary Syndrome (PCOS) patients with insulin resistance (IR). Methods: A single center, prospective, randomized open-label study (ratio 1:1), non-inferiority trial was conducted in the department of endocrinology, Shanghai Tenth People's Hospital between July 2019 and April 2021. PCOS women aged 18-45 years with IR were enrolled and randomly assigned to either canagliflozin 100 mg (n = 33) or metformin 1500-2000 mg (n = 35) daily for 12 weeks. The primary outcome was changes in HOMA-IR after 12 weeks treatment. The secondary outcomes included changes in anthropometric, menstrual frequency, sex hormone and metabolic parameters.

Eligibility Criteria:
Inclusion criteria:

* Fmale aged 18- 45;
* Meet Rotterdam criteria;
* Insulin Rsistance

Exclusion Criteria:

* Women who are pregnant or have a pregnancy plan within six months; ·Congenital adrenocortical hyperplasia;
* Hyperprolactinemia;
* Hyperthyroidism or hypothyroidism;
* Abnormal liver function (≥ 3 times of the upper limit of normal range);
* Abnormal renal function (GFR\<60ml/min/1.73m2);
* Adrenal or ovarian tumors secreting androgens;
* Used contraceptives, metformin, GLP-1RA, SGLT2I, pioglitazone and contraceptives in the last 3 month.
Evaluation of Cardiac Function With Cardio-respiratory Synchronized MRI

The purpose of this investigation is to evaluate newer methods of performing cardiovascular MRI (CMR) that will provide new kinds of information related to the interplay between the cardiac and the respiratory cycles, such as the interaction between the left ventricle and the right ventricle during respiration . The primary statistical objective is to provide preliminary indications of the relative utility of the investigational imaging software in terms of image quality and suitability for routine clinical use. Image quality will be expressed in terms of signal-to-noise ratios (SNR), contrast-to-noise ratios (CNR) and subjective Likert-type qualitative assessments independently provided by each of multiple blinded readers for each image. Suitability for routine use will be assessed in terms of imaging time and a binary indicator of whether, in the opinion of the investigator, adverse procedural complications (not expected) were encountered during a given imaging session.


Eligibility Criteria:
Inclusion Criteria:

* Subjects will be selected as they are scheduled for clinical MR examinations.
* Subjects will be selected on the basis of their willingness and ability to participate, on their comprehension of the informed consent document, on their likelihood of completing the study, and on the clinical appropriateness of the investigational technique for a given patient.

Exclusion Criteria:

* electrical implants such as cardiac pacemakers or perfusion pumps
* ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants
* ferromagnetic objects such as jewelry or metal clips in clothing
* pre-existing medical conditions including a likelihood of developing seizures or claustrophobic reactions, and any greater than normal potential for cardiac arrest.
Pregabalin Versus Dexmedetomidine for Delirium Prevention After Cardiac Surgery

The aim of this study is to compare the effect of perioperative administration of pregabalin versus dexmedetomidine on the prevalence and lasting duration of delirium in elderly patients after cardiac surgery.

Pregabalin is a beta-isobutyl of GABA with chemical similarity to gabapentin . Pregabalin binds to the alpha-2-delta subgroup of calcium channels, thereby reducing excitatory neurotransmitter release and preventing hyperalgesia and central sensitization . Pregabalin is used as anticonvulsant but has also been used as analgesic for neuropathic pain and, lately, for postoperative pain, in an attempt to reduce opioid consumption and prevent progression to chronic pain.

Dexmedetomidine with its broad range of effects including easily controllable sedation, analgesia, and anxiolysis still enables the caring medical team to interact with the patient. It reduces the activity while still maintaining the reactivity of neurons in the locus coeruleus. Therefore, it is an appealing alternative to traditional sedatives such as propofol and benzodiazepines.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 65 years of age both genders American Society of Anesthesiologists (ASA) physical status classification II or III scheduled for cardiac surgery.

Exclusion Criteria:

* Patients who had history of psychiatric diseases; inability to communicate; previous history of POD; preoperative sick sinus syndrome.
* Allergy/sensitivity to pregabalin or dexmedetomidine.
* Severe bradycardia (heart rate \<50 beat per minute).
* Second-degree or above atrioventricular block without pacemaker.
* Severe hepatic or renal insufficiency.
* Previous cardiac or thoracic surgery.
* Known diagnosis of depression or other major psychiatric diseases.
* Cognitive impairment or inability to cooperate with the study.
* Renal insufficiency, and history of substance abuse.
Autophagy in Systemic Lupus Erythematosus

Systemic lupus erythematosus is systemic autoimmune disease characterized by a wide range of clinical manifestations, from skin and mucosal lesions to severe injuries in the central nervous system, kidneys and other organs. The presence of high titres of autoantibodies against nuclear components, immune complexes deposition, complement deficiency and lymphocytes infiltration in affected tissues, which causes tissue and organ damage are the main characteristics of the disease. Nowadays, many studies elucidate the essential role of autophagy in the occurrence, development and severity of systemic lupus erythematosus.

Autophagy is a highly conserved lysosome-mediated catabolic process. It can remove unwanted cytoplasmic components, such as long-lived and/or misfolded proteins, damaged organelles, playing an important role in maintaining cellular homeostasis and cell survival in stress conditions, such as nutrient deprivation and hypoxia.

Recently, Autophagy is implicated in nearly all steps of both innate and adaptive immune responses, including neutrophil extracellular trap and inflammasome formation, pathogen recognition, lymphocyte and monocyte development and function, antigen processing and presentation, type I interferon production and inflammatory regulation, thus playing an important part in maintaining the balance of immune system.

Autophagy is divided into three major types: macroautophagy, microautophagy, and chaperone-mediated autophagy, with macroautophagy being the most investigated and understood. Disturbances in autophagy have been implicated in chronic inflammatory diseases and several autoimmune diseases, including Systemic lupus erythematosus, multiple sclerosis, Crohn's disease and rheumatoid arthritis.

Several regulatory factors that may play key roles in autophagy processes have been discovered in recent years, such as beclin1, which is the key regulatory factor in the autophagy startup process, microtubule-associated protein-light chain 3, autophagy-related gene 5, which are components of autophagosomes.

Eligibility Criteria:
Inclusion Criteria:

* patients who fulfilled at least four criteria of systemic lupus erythematosus according to American College of Rheumatology

Exclusion Criteria:

* Pregnancy or lactation.
* coexistence of other autoimmune diseases.
Mixed Incontinence: Medical Or Surgical Approach?

The purpose of this study is to compare treatment outcomes for patients with mixed urinary incontinence (MUI) for whom therapy is initiated with surgery to those for whom therapy is initiated with non-surgical treatment. Women who are bothered by symptoms of both stress and urge incontinence will be randomly assigned to initiate treatment with a surgical (surgery for stress incontinence) vs. a non-surgical (drug and behavioral therapy) approach. Follow-up will be a minimum of 12 Months.

The purpose of this study is to compare treatment outcomes for patients with mixed urinary incontinence (MUI) for whom therapy is initiated with surgery to those for whom therapy is initiated with non-surgical treatment. Women who are bothered by symptoms of both stress and urge incontinence will be randomly assigned to initiate treatment with a surgical (surgery for stress incontinence) vs. a non-surgical (drug and behavioral therapy) approach. Follow-up will be a minimum of 12 Months.

Eligibility Criteria:
Inclusion Criteria:

1. Female
2. Mixed UI as evidenced by stress and urge symptoms reported on MESA (either percent of urge-type symptoms ≥ the percent of stress-type symptoms or urge symptom score ≥7 if stress predominant) followed by report of "moderately" or "greatly"/"quite a bit" bothered to questions 2 and 3 of the 6-item Urinary Distress Index (UDI-6) or questions 16 and 17 of the 20-item Pelvic Fl;oor Distress Index (PFDI-20), respectively (See Appendix C)
3. Moderate or severe UI as evidenced by the corresponding response on the Patient Global Impression of Severity (PGI-S)
4. Incontinence symptoms present for at least (3) months\*
5. Bladder capacity \> 200cc (by any method)
6. Urodynamic Stress Incontinence
7. Eligible for both treatment interventions
8. Available to start intervention within 6 weeks
9. Negative urine dipstick (negative result = trace or less for leukocytes \& nitrites)
10. Available for 12 months of follow-up and able to complete study assessments as per clinician judgment
11. Signed consent form

Exclusion Criteria:

1. Age \<21 years\*
2. Currently undergoing or recommended to undergo treatment of pelvic organ prolapse
3. Other indicated/planned concomitant surgery
4. Pregnant or has not completed child bearing\*
5. \<12 months post-partum\*†
6. Active malignancy of cervix, uterus, fallopian tube(s) or ovary \> Stage I, or bladder of any Stage
7. Current catheter use
8. Unevaluated hematuria
9. Participation in another trial that may influence the results of this study

   * Patient can be rescreened after respective time interval has been met. †"Partum" is defined as a delivery or other termination that occurs after 20 weeks gestation.
Comprehensive Oncology Measures for Peripheral T-cell Lymphoma Treatment Registry

Prospective, longitudinal, multinational, observational study that will collect data on how patients with peripheral T-cell lymphoma (PTCL) are treated in academic and community practices.

The COMPLETE registry is a prospective, longitudinal, multinational, observational study that will collect data on how patients with peripheral T-cell lymphoma (PTCL) are treated in academic and community practices. The registry will enroll newly-diagnosed patients with PTCL treated with a variety of regimens. The COMPLETE registry is designed to better understand PTCL patient characteristics, treatments, and outcomes to help design and understand future clinical trials.

Eligibility Criteria:
Inclusion Criteria:

* Patient is newly diagnosed with Peripheral T-cell Lymphoma (PTCL):

  * Aggressive natural killer (NK)-cell leukemia
  * Adult T-cell lymphoma/leukemia (human T-cell leukemia virus \[HTLV\] 1+)
  * Angioimmunoblastic T-cell lymphoma
  * Anaplastic large cell lymphoma (ALCL), primary systemic type (ALK+, ALK-)
  * PTCL, not otherwise specified (NOS)
  * T/NK-cell lymphoma, nasal type
  * Enteropathy-type intestinal lymphoma
  * Hepatosplenic T-cell lymphoma
  * Subcutaneous panniculitis T-cell lymphoma
  * Transformed mycosis fungoides (at diagnosis of transformation)
  * T-cell prolymphocytic leukemia (T-PLL)
  * Cutaneous gamma/delta (γ/δ) T-cell lymphoma
  * Cutaneous aggressive CD8+ T-cell lymphoma
  * Hematodermic neoplasms (blastic plasmacytoid dendritic cell neoplasm)
  * Systemic Epstein Barr Virus (EBV)+ T-cell lymphomas (T-cell lymphoproliferative disorders of childhood)
  * Other T-Cell lymphomas that are not listed in the Exclusion Criteria
* Patient gives written informed consent

Exclusion Criteria:

* Patient has other T- or NK-cell malignancies including:

  * Precursor T/NK neoplasms
  * T-cell large granular lymphocytic leukemia
  * Mycosis fungoides, other than transformed mycosis fungoides
  * Sézary syndrome
  * Primary cutaneous CD30+ disorders: ALCL and lymphomatoid papulosis
Occlusal Adjustment as Treatment for Chronic Orofacial Pain

The purpose of this study is to determine whether occlusal adjustment by selective grinding and/or occlusal addition is an effective treatment of chronic temporomandibular joint disorders.

Temporomandibular disorders (TMD) are very common disorders in daily dentistry and oral and maxillofacial practice. The key symptoms are jaw joint pain and limited mouth opening. Other than trauma, the causes remain unknown; consequently, there are no treatments based on specific etiologies. In our experience, patients can usually receive beneficial occlusal adjustments if these are carefully planned and performed in two steps: (1) elimination of premature contacts, which reduces loads in the temporomandibular joints, and (2) individualized remodeling of lateral anterior guidance to facilitate unilateral alternate chewing. The study will use stratified blocking randomization to blindly assign patients to the real or placebo treatment groups in order to evaluate the null hypothesis (H0) that "Occlusal adjustment of sufficient quality has no effect on chronic pain and/or limited mouth opening in TMD patients."

Eligibility Criteria:
Inclusion Criteria:

* People suitable for inclusion in the study are full dentate patients
* Aged between 18 and 65 years
* Patients with chronic TMD pain (and usually with associated limited mouth opening) for whom occlusal adjustment could achieve normal occlusion, both static and functionally equilibrated

Exclusion Criteria:

* Pregnancy
* Trauma
* Previous TMJ surgery
* Patient refusal to consent to participate in the study or significant concerns about the study
* Limited collaboration
* Concurrent active treatment with orthodontics, and active periodontal disease
Magnetic Ressonance Imaging of Temporomandibular Joint

Background: Among the instrumental devices that have been proposed over the years to integrate the clinical evaluation of temporomandibular joint disorders (TMD), imaging techniques are the most studied, showing that magnetic resonance imaging (MRI) is the technique most need to describe the anatomy of the TMJ and to evaluate the correlation of imaging findings with the clinical diagnosis . Despite the amount available studies on the use of MRI for evaluation of TMJ disorders and treatments, there is a lack of studies that evaluate the imaging findings after physical therapy. Purpose: To evaluate the influence of nonspecific mandibular mobilization about the positioning of the articular disc by MRI in individuals with TMD diagnosis of anterior disc displacement with and without reduction according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD). Analyze the behavior of pain through the numerical scale of pain assessment (END) at baseline and after each treatment session, the quality of life of individuals with TMD at baseline, immediately, three and six months after the treatment sessions by the World Health Organization Quality of Life Assessment (WHOQOL - BREF), and The Patient's Specific Functional Scale (PSFS) at baseline and after treatment. The treatment will be performed three times a week during four weeks. Metodology: This is a randomized, placebo controlled, blind study designed to assess the effects of techniques nonspecific mandibular mobilization x placebo. Individuals will be randomized and divided into two groups: Group A (intervention) and Group B (placebo). Statistic analysis: The positioning of the articular disc, extracted through the use of MRI, will be considered the primary outcome and, as a secondary outcome will be assessed the quality of life, pain and function after treatment. The adherence of the data to a Gaussian curve will be verified by the Shapiro-Wilk and the data are expressed as mean values and standard deviation. Two-way repeated measures analysis of variance with Bonferroni post hoc test will be used for inter-and intra-group comparisons. The significance level is adjusted p ≤ 0.05.

This is a randomized, placebo-controlled, double-blind study designed to verify the effects of nonspecific mandibular mobilization techniques x placebo

Eligibility Criteria:
Inclusion Criteria:

* TMD diagnosed subjects by RDC / TMD confirmed by the MRI findings,
* with anterior disk displacement with or without reduction,
* with full dentition (excluding third molars).

Exclusion Criteria:

* Subjects diagnosed TMD exclusively muscular;
* with posterior and / or medial displacement of the disc;
* showing systemic diseases that affect the joints and / or masticatory muscles;
* neuromuscular diseases;
* hypo / condylar hyperplasia;
* making use of any type of dental prosthesis;
* are in orthodontic and / or physical therapy;
* showing neurological or behavioral disorders that preclude the achievement of MRI and/or
* a history of previous TMJ surgery.
Mitral Insufficiency Reduction With Biventricular Pacing

The purpose of this study is to show that CRT(Cardiac Resynchronization Therapy) pacing in patients with severe functional MR (Mitral Regurgitation) who are not currently indicated for CRT will demonstrate chronic benefit of MR reduction( via echo measured MR/LA area and ERO per American Society of ECHO guidelines) and to show that CRT pacing is safe in these patients.

Approximately 50 patients will be randomized, followed and analyzed in this prospective study. Patients who meet all inclusion and no exclusion criteria will be enrolled and implanted with a CRT system. Baseline evaluation, which includes clinical symptom evaluation and an echocardiogram, will be performed at the time of randomization, which should occur as soon after device implant as possible but no later than 2 week post -implant. The baseline echocardiogram should be acquired prior to the device being programmed to the randomized setting. Repeat echocardiograms and scheduled follow-up evaluations will be performed at the end of each 3 month crossover period.

Eligibility Criteria:
Inclusion Criteria:

* Patient is at least 18 years of age
* Patients with moderate-to-severe or severe functional MR.

  * EROA \> 40 mm2 and an MR/LA \> 40% (severe)
  * 30 ≤ EROA ≤ 40 mm2 and 30 ≤ MR/LA ≤ 40% (moderate-to-severe)
* Baseline rates of 50-90 beats per minute (patients with sinus rhythm) or AF
* QRS \< 120 ms
* LVEF \< 35%
* Willing to sign informed consent
* On standard stable heart failure medical regimen (beta blockers and ACE-I or ARBs) for at least 1 month before randomization, if tolerated
* Patient has the ability to understand the requirements of the study, including consent for use and disclosure of research-related information
* Patient has the ability to comply with study procedures and protocol, including required study visits

Exclusion Criteria:

* candidate for CRT or has a previously implanted CRT device
* previously implanted implantable pulse generators (IPG) or implantable cardioverter defibrillator (ICD) with at least 10 % pacing in the right ventricle
* patient has life expectancy \<6 months
* patient is pregnant
* significant aortic stenosis
* uncontrolled hypertension
* mitral valve stenosis
* severe mitral valve calcification
* ruptured chordae tendinae or papillary muscle
* mitral valve leaflet disorders (i.e. endocarditis, lupus, tumors, rheumatic heart disease)
* chronic mitral leaflet degeneration (ie. Marfans)
* previous valve replacement or surgery
* IV inotropes or IV vasodilators
* candidate for mitral valve repair or replacement surgery within the next 6 months
* patient has in-hospital acute coronary syndrome (ACS) (NSTEMI/STEMI) prior to randomization
* patient has planned or elective percutaneous coronary intervention (PCI) or other non-cardiac surgery prior to randomization
* patient is currently enrolled in an investigational drug or device study
* patient is clinically unstable per PI assessment