cyrilzakka/clinical-trials huggingface dataset:
Identifying Biomarkers and Changes in Cerebrospinal Fluid Collected Pre and Post Spinal Cord Stimulation in Subjects Suffering From Chronic Refractory Pain Conditions

This is a single center exploratory study in subjects suffering from chronic refractory pain to identify cellular, molecular and protein biomarkers within cerebrospinal fluid (CSF).

The study aims to identify any form of correlation between biological content of CSF and pain/treatment success. The study population include individuals suffering from chronic pain which has not been effectively treated with pharmacological treatment, medical intervention or alternative non-invasive treatments who have been scheduled for spinal cord stimulation.

This is a single centre exploratory study in individuals suffering from chronic refractory pain to identify cellular, molecular and protein biomarkers within cerebrospinal fluid (CSF).

The investigators aim to identify any form of correlation between biological content of CSF and pain/ spinal cord stimulator (SCS) therapy success. '

CSF will be sampled before and after SCS therapy, the samples will be analysed to explore and identify biomarkers that are potentially relevant to the chronic pain conditions

. All eligible participants who are enrolled in the study will undergo screening assessment. Specifically, assessments will include pain scores assessed by Visual Analogue Scale (VAS), quality of life as assessed by the EQ-5D, disability as assessed by the Oswestry Disability Index (ODI), quality of sleep as assessed by Pittsburgh Sleep Quality Index (PSQI), Pain sensation as assessed by Pain Map and neuropathic pain as assessed by Douleu Neuropathique 4 (DN4).

During trial implant participants will have CSF sample taken using lumbar puncture technique.

Following collection CSF sample will be analysed to Identify potential biomarkers.

All participants will return to the clinic 14 (± 7) days following the procedure to assess the outcome of their SCS trial and complete assessments which include Pain Map, Pain VAS, DN4 , PSQI , ODI , EQ-5D and Patients Global Impression of Change (PGIC).

Following this participants will be followed up for end of study visit. The second CSF sample will be taken at this visit using lumbar puncture technique. At this visit participants will further be asked to complete assessments including Pain Map, Pain VAS, DN4 , PSQI , ODI ,EQ-5D and PGIC.

Eligibility Criteria:
Inclusion Criteria:

1. Be capable of understanding and signing a written consent form
2. Subjects suffering from chronic neuropathic pain which has not been effectively managed with pharmacotherapy, medical interventions or alternative non-invasive treatments
3. Pain VAS score ≥ 5 on more than 3 days a week at least over three months.
4. Subjects deemed a suitable candidate receive spinal cord stimulator device as determined by a pain management specialist
5. No known contraindication to spinal cord stimulation
6. Does not have an active systemic or local infection

Exclusion Criteria:

1. Structural abnormalities of the spine at L2-L3 that may impact study procedure
2. Severe scoliosis
Clinical Characteristics of Lip Hemangiomas

Lip hemangiomas are at higher risk than those located in other sites. However, studies about clinical characteristics of lip hemangiomas have not been enough. The investigators want to conduct a prospective study on the clinical features of lip hemangiomas.

Hemangiomas involving lip are of special concern, since they occur in a prominent location on the face and can distort lip anatomy and lead to disfunction. Infantile hemangiomas in lip had significantly higher incidence than the others. It is often difficult to decide which patient with an lip hemangioma is at higher risk.

The investigators are interested in conducting a study on the clinical features of lip hemangiomas. The investigators are collecting medical records and photos of lip hemangiomas, including demographic information, maternal process, birth, location, size and complication. Based on the data, sum up the main points of clinical characteristics and complication.

Eligibility Criteria:
Inclusion Criteria:

* Only lip hemangiomas visiting between June 1, 2010 and October 1, 2014 were included in this study, which was defined as any infantile hemangioma covering any part of vermilion.

Exclusion Criteria:

* Perioral hemangiomas which did not involve vermilion were excluded.
Investigation of the Effect of "Curtain" Use on Self-Injection, Testing Fear and Pain in Patients With Type 2 Diabetes

Diabetes is a global problem for the world and negatively affects life (1). The most important reasons for ineffective diabetes and insulin treatment include fear of insulin side effects, fear of insulin injection, social embarrassment from administering insulin, fear of hypoglycemia and/or hyperglycemia (2). A large portion of diabetic individuals experience these fears, and some of these patients cope with these fears and integrate them into their daily lifestyles. However, some diabetic patients may be ineffective in coping with these fears (3). This situation creates negativities in the individual's success in treatment and compliance with treatment (3). Diverting attention is one of the non-pharmacological methods used in pain control. Diverting attention is one of the most preferred methods in reducing the pain experienced by patients during diagnosis and treatment procedures. It is a method that allows patients to control and reduce their symptoms by focusing their attention on a different point (4). In this study, the use of a distracting curtain during self-injection in individuals with Type 2 diabetes will be examined in order to examine the effect of pain and fear.

Research Type:

It is designed as a randomized controlled, regular research.

Research Universe and Samples:

The research groups will be the living diabetes cells of Dicle University Hospitals. The research aims to create 100 healthy diabetes patients in Dicle University Hospital.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes for at least one year
* self-administering insulin injections
* self-administering a glucometer, insulin pen or insulin pump,

Exclusion Criteria:

* poor mental health
* Having gestational diabetes mellitus or Type 1 Diabetes
Tolerance of Chlorhexidine Gluconate Vaginal Cleansing Solution

Conduct a randomized control study to compare the tolerance of 4% chlorhexidine gluconate/4% isopropyl alcohol versus povidone iodine vaginal cleansing solutions for surgical preparations of the vagina. Patients will be randomized to either control (povidone iodine) or experimental (chlorhexidine gluconate), and then be given a short survey prior to and immediately after surgery, and again 24-48 hours via phone asking them about the presence and severity of vaginal dryness, burning, itchiness, unusual vaginal discharge, and pain or burning with urination.

Surgical site antisepsis is critical in preventing surgical site infections. Although chlorhexidine gluconate has proven to be superior to povidone iodine for surgical site antisepsis, povidone iodine is the only FDA-approved antiseptic solution for surgical preparation of the vagina. Many surgeons are hesitant to use chlorhexidine gluconate for preoperative vaginal cleansing due to the alcohol dissolvent present in the solutions that is implicated in a greater risk of irritation. Yet, there has been no randomized study to illustrate whether the risk of vaginal irritation is greater in chlorhexidine gluconate versus povidone iodine. Thus, the purpose of the study is to conduct a randomized control trial to compare the tolerance of 4% chlorhexidine gluconate to povidone iodine using patient-reported outcomes of vaginal or urinary symptoms. Patients will be randomized to either control or experimental, and then be given a short survey prior to and immediately after surgery, and again 24-48 hours via phone asking them about the presence and severity of vaginal dryness, burning, itchiness, unusual vaginal discharge, and pain or burning with urination.

Eligibility Criteria:
Inclusion Criteria:

1. Undergoing hysteroscopy
2. Gynecologic dilation \& curettage
3. Endometrial ablation
4. Essure without concomitant laparoscopy

Exclusion Criteria:

1. Pregnant
2. Have a history of atopic dermatitis, vaginal irritation, allergic reactions, or anaphylaxis to chlorhexidine gluconate or povidone iodine.
Treatment Study of Denintuzumab Mafodotin (SGN-CD19A) Plus RICE Versus RICE Alone for Diffuse Large B-Cell Lymphoma

The purpose of this randomized, open-label study is to evaluate the safety and efficacy of denintuzumab mafodotin plus RICE (rituximab, ifosfamide, carboplatin, and etoposide) when compared to RICE alone in the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or Grade 3b follicular lymphoma. Eligible patients must also be candidates for autologous stem cell transplant. Patients will be randomly assigned in a 1:1 ratio to receive 3 cycles of study treatment with either denintuzumab mafodotin + RICE or RICE alone. The study will assess whether there is a difference between the 2 groups in the side effects that are reported and the number of patients who achieve complete remission at the end of their study treatment.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed diagnosis of relapsed or refractory diffuse large B-cell lymphoma (DLBCL; including de novo and transformed DLBCL) or Grade 3b follicular lymphoma
* Available representative tissue from the most recent biopsy after the last therapy; if such tissue is not available, a fresh biopsy must be obtained
* Received only frontline CD20-directed immunotherapy with anthracycline- or anthracenedione-based multi-agent chemotherapy. Monotherapy rituximab or other CD20-directed immunotherapy as maintenance therapy prior to frontline chemotherapy, and radiotherapy in a limited field or as part of the frontline treatment plan are permitted.
* Achieved a response of stable disease, partial response, or complete response following the last cycle of frontline treatment. In addition, patients must have relapsed less than or equal to 6 months from the completion of frontline therapy at the time of initial dosing in this clinical trial.
* Considered eligible for high-dose chemotherapy followed by autologous stem cell transplant (ASCT)
* Fluorodeoxyglucose (FDG)-avid disease by positive emission tomography (PET), and measurable disease greater than 1.5 cm in diameter
* Eastern Cooperative Oncology Group (ECOG) performance less than or equal to 2
* Adequate kidney and hematologic function assessed from baseline laboratory data

Exclusion Criteria:

* Previous history of indolent lymphoma treated with more than 1 multi-agent chemotherapy regimen or previous cancer therapy for recurrent DLBCL or Grade 3b follicular lymphoma
* History of autologous or allogeneic stem cell transplant
* History of another primary invasive cancer, hematologic malignancy, or myelodysplastic syndrome that has not been in remission for at least 1 year
* History of progressive multifocal leukoencephalopathy (PML)
* Cerebral/meningeal disease related to the underlying malignancy that has not been definitively treated
* Known urinary tract obstruction
* Patients with the following ocular conditions: corneal disorders, monocular vision (i.e., best corrected visual acuity greater than or equal to 20/200 in one eye), or active ocular disorders requiring treatment
Preheated Composites Vs. Conventional Composites in Noncarious Cervical Lesions

Preheating resin composites is the warming of resin composites by using a heating device (composite warmer) before its placement. Preheating increases the flow properties and allows better adaptation to cavity preparation. The high thermal energy also improves polymerization rate, thereby reducing microleakage. Conventional composites resin is used as one-paste light-cured systems, which are built up in increments to overcome the effects of setting shrinkage and to ensure thorough curing.

Several studies report failure of cervical restorations of noncarious cervical lesions and an incessant search for the most suitable restorative material. Therefore, this study aims to evaluate the clinical performance of conventional resin composites compared with preheated resin composites in the treatment of noncarious cervical lesions. Our null hypothesis states that there is no difference between the clinical performance of preheated resin composites and conventional resin composites in the treatment of noncarious cervical lesions.

This study will be conducted at the Conservative and Endodontics Department in Polyclinic B, Faculty of Dentistry, Manipal University College Malaysia (MUCM). It involves forty-six randomly selected patients with two similar noncarious cervical lesions, each on a canine, first premolar, second premolar or first molar on the contralateral side of the maxillary arch. One lesion will be restored with preheated resin composite (3M™ Filtek™ Z350 XT Universal Restorative) while the other lesion will be restored with conventional resin composite (3M™ Filtek™ Z350 XT Universal Restorative). Both restorations will be done on each patient's first visit. The patients will be recalled 1,3 and 6 months later for assessment of the restorations, using modified US Public Health Service (USPHS) criteria: marginal integrity, marginal discoloration, wear, retention, secondary caries and postoperative sensitivity.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are systemically healthy (ASA I and ASA II )44 and have satisfactory oral hygiene (OHI-S score of 0 to 3.0).
* Participants must have two noncarious cervical lesions (abrasion/abfraction), each on a canine, 1st premolar, 2nd premolar or 1st molar on the contralateral side of same dental arch (maxillary arch) with similar depth and width.
* Both NCCLs are in contact with antagonist teeth as well.

Exclusion Criteria:

* Participants requiring dental prostheses of the target teeth.
* Participants have a diagnosis of caries coincident with the cervical lesion, or an indication for irreversible endodontic treatment of the target teeth.
* Existence of periodontal damage with respect to the target teeth.
Influence of Central Nervous Insulin Action on Insulin Sensitivity of Peripheral Organs in Lean Versus Overweight Humans

Research in animals and first experiments in humans indicate that insulin action in the brain regulates peripheral insulin sensitivity. One major organ might be the liver. Previous studies in humans showed that the human brain is an insulin sensitive organ in lean but not in overweight/obese persons. Therefore, this study will include lean versus overweight/obese persons.

In this study, insulin action will be introduced by intranasal insulin administration in lean and overweight humans. As a control, placebo spray will be administered. To mimick the known spill over of small amounts of intranasal insulin into circulation, a small bolus of insulin will be administered over 15 minutes following placebo spray application.

Peripheral insulin sensitivity will be assessed by hyperinsulinemic-euglycemic glucose clamp and glucose uptake and endogenous glucose production will be assessed by tracer dilution technique. Autonomous nervous system activity will be addressed by heart rate variability. Involved brain areas will be addressed by fMRI before and after nasal insulin application.


Eligibility Criteria:
Inclusion Criteria:

* Male volunteers (lean or overweight/obese)
* HbA1c \<6.0%
* Age between 18 and 40 years
* healthy as assessed by physician
* Understanding the explanations about the study and instructions

Exclusion Criteria:

* non-removable metal parts in or on the body
* Persons with reduced temperature sensation and / or increased sensitivity to warming of the body
* Cardiovascular disease can not be excluded, such as evident coronary heart disease, congestive heart failure NYHA greater than 2, history of coronary artery disease
* History of stroke
* Persons with a hearing disorder or increased sensitivity to loud noises
* People with claustrophobia
* Subjects in which less than 3 months have passed since surgery
* Simultaneous participation in other studies
* Acute disease or infection within the last 4 weeks
* Neurological and psychiatric disorders
* Subjects with hemoglobin Hb \<13g / dl
* Heparin-induced thrombocytopenia people with a (HIT) in prehistory
* Allergies to any of the used solutions/devices
Dynamic Changes of Serum HBV RNA in Chronic Hepatitis B Patients

Some patients with low-level viremia (LLV) are also likely to develop hepatocellular carcinoma (HCC) or other liver diseases. The relationship between HBV RNA levels and fibrosis in patients with HBV DNA negative or LLV is still lacking evidence. The purpose of this study is to observe the differences in HBV RNA levels and their association with efficacy in HBV DNA negative or LLV patients. Investigators conduct the prospective, single-center, non-randomized, observational clinical study. A total of 100 chronic hepatitis B (CHB) patients who receive antiviral therapy with nucleoside (acid) analogues for 1-3 years will be enrolled. The enrolled patients will be followed up five times to collect clinical data and record adverse events (at baseline, week 12, week 24, week 36 and week 48, respectively).


Eligibility Criteria:
Inclusion Criteria:

* 1.18 years old or above and the gender is not limited;
* 2. Patients who receive antiviral therapy with nucleoside (acid) analogues for 1-3 years ;
* 3. Patients with HBV DNA negative (HBV DNA\<20 IU/ml) or LLV（HBV DNA 20-2000 IU/mL）
* 4. Good compliance and voluntary signing of informed consent.

Exclusion Criteria:

* 1. Patients with decompensated cirrhosis;
* 2. Patients co-infection with other viruses, such as hepatitis A virus, hepatitis C virus, hepatitis D virus, hepatitis E virus, HIV virus, etc.;
* 3. Patients with significant renal, cardiovascular, pulmonary, or neurological disease;
* 4. Patients have active or suspected malignancy or history of malignancy;
* 5. Patients who were identified not appropriate for the study by investigators.
MAgnetic Resonance Imaging-guided implanTation of Cardioverter DEFibrillators

Implantable cardioverter-defibrillators (ICD) are currently recommended for the primary prevention of sudden cardiac death (SCD) in patients with a remote (\>6 weeks) myocardial infarction (MI) and a low (≤35%) left ventricular ejection fraction (LVEF).

Ventricular tachycardia (VT) and/or ventricular fibrillation (VF), which are responsible for most SCDs, result from the presence of surviving myocytes embedded within fibrotic MI-scar. The presence of these surviving myocytes, as well as their specific arrhythmic characteristics, is not captured by LVEF. Hence, the use of LVEF as a unique risk-stratifier of SCD results in a low proportion (17 to 31%) of appropriate ICD device therapy at 2 years. Consequently, most patients with a prophylactic ICD do not present VT/VF requiring ICD therapy prior to their first-ICD battery depletion. Thus, many patients are exposed to ICD complications, such as inappropriate shocks, without deriving any health benefit. Therefore, the current implantation strategy of prophylactic ICDs, based on LVEF only, needs to be improved in post-MI patients.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years;
* Patients with a LVEF≤35% assessed at least after a 40 to 90 days period (depending on the presence of coronary revascularization) following an index myocardial infarction;
* Left ventricular systolic impairment as defined by LVEF≤35% by any current standard technique (echocardiogram, multiple gated acquisition scan, or MRI) within 2 months;
* Able and willing to comply with all pre-, post- and follow-up testing, and requirements;
* Use of maximum tolerated doses of ACE inhibitors (or Angiotensin II Receptor Blockers if intolerant of ACE) and Beta Blockers and MRA as per ESC guidelines;
* Person affiliated to or beneficiary of a social security plan
* Person informed about study organization and having signed the informed consent

Exclusion Criteria:

* History of cardiac arrest or sustained VT or VF unless within 48 hours of an acute myocardial infarction;
* Standard contraindications for cardiac LGE-MRI;
* Hypersensitivity to gadolinium-based contrast agent;
* Currently implanted permanent pacemaker and/or ICD;
* Patient refusal of ICD/ILR implantation;
* Currently implanted permanent pacemaker and/or ICD;
* Clinical indication for or Cardiac Resynchronization Therapy (CRT);
* Severe renal insufficiency defined by a glomerular filtration rate (GFR) \< 30 mL/min/1.73m²;
* Recent PTCA (within 30 days) or CABG (within 90 days);
* Baseline NYHA functional class IV;
* Contraindication for ICD implantation according to current guidelines;
* Woman of childbearing age without effective contraception;
* Person referred in articles L.1121-5, L. 1121-7 and L.1121-8 of the French Public Health Code.
Long-term Results of Bilateral Thoracoscopic Ablation for Stand-alone Atrial Fibrillation

Atrial fibrillation (AFib) represents the most frequent cardiac arrhythmia whose prevalence appears to be increasing in the general population. Furthermore, this arrhythmia determines an increased risk of neurological complications (stroke) and, consequently, of mortality and morbidity.

Currently, the first choice for the treatment of AFib is represented by the use of antiarrhythmic drugs. In patients who do not respond to pharmacological treatment, the ESC 2016 European guidelines recommend the execution of transcatheter ablation (Class I, level of evidence A). However, minimally invasive pulmonary vein isolation surgery (PVI) is recommended for subjects who are not even responsive to transcatheter ablation (Class IIa, Level of Evidence B).

Previous studies have demonstrated good short-term results of thoracoscopic AFib ablation using PVI, with a 1-year freedom from atrial fibrillation recurrence without antiarrhythmic drugs of approximately 64-73%. However, only a few authors have described the medium-long term follow-up outcomes.

The aim of this study is to report the long-term follow-up data of ablation of isolated, predominantly paroxysmal atrial fibrillation performed by isolation of the pulmonary veins by radiofrequency in bilateral thoracoscopy.


Eligibility Criteria:
Inclusion Criteria:

* Age between 20 and 80 years old;
* Isolated atrial fibrillation (predominantly paroxysmal);
* Patients undergoing ablation of atrial fibrillation (both paroxysmal and persistent) by isolation of the pulmonary veins by radiofrequency in thoracoscopy.

Exclusion Criteria:

* Age under 20 or over 80;
* Previous trauma/deformity of the rib cage limiting the thoracoscopic approach;
* Previous pleurisy or thoracic operations (e.g. lobectomies) conditioning the possible appearance of pleural adhesions limiting the thoracoscopic approach.