cyrilzakka/clinical-trials huggingface dataset:
Sleep and Neuropathic Pain - Intervention Study on Pregabalin

The goal of this clinical study is to study sleep and its microstructure in neuropathic pain patients who have or who do not have a clinically significant sleep disturbance, before and during (after 1-month stabile dosage) pregabalin treatment. To find out whether reduced pain by pregabalin associates with improved sleep quality; to study, using resting state fMRI, brain network connectivity and the volume of the choroid plexus before and during pregabalin treatment (after dosage stable for one month) at baseline and during stabile treatment with pregabalin, and to compare the usability and reliability of sleep-related information collected with sleep diaries, actigraphy, iButtons, and ambulatory polysomnography in peripheral painful neuropathy patients. The main questions it aims to answer are:

* Is pregabalin more efficacious in neuropathic pain patients who suffer from insomnia compared to those with no clinically meaningful sleep disturbance?
* Does sleep disturbance due to pain associate with brain network connectivity and may these changes be reversed by pregabalin treatment? Participants will
* Fulfill e-questionnaires and keep sleep diary before and after 1month stabile pregabalin intervention
* Before and after 1-month stabile pregabalin medication: 1-week Actiwatch monitoring, iButton (1 day and night), ambulatory polysomnography (1 night), brain fMRI.

Researchers will compare patients with high ISI score patients to see if they benefit more from pregabalin treatment than those with low ISI score.

This is a clinical study to analyze sleep and pain and their response to pregabalin in 40 patients aged 18 to 75 years with chronic (duration\>3 months) moderate to severe pain (NRS ≥ 4/10) due to peripheral neuropathy. The investigators divide patients to two groups according to scores in ISI: the ones with clinically significant insomnia with score 15 or more (ISI High) and the ones without marked insomnia with score 14 or lower (ISI Low). Sleep will be assessed by a sleep diary, iButton, polysomnography and 1-week Actiwatch monitoring before and after 1-month stabile pregabalin dosage. Additionally, at these time points, several questionnaires regarding pain, sleep, mood, and quality of life and functional brain MRI will be performed. At pregabalin administration, the dose is added three to four day intervals, if tolerated by the patient. After a maximum tolerated dose has been stable for 1 month, the sleep studies, questionnaires, and brain fMRI are repeated. The study duration is about 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Chronic (duration \> 3 months) painful peripheral neuropathy
* Pain moderate to severe (NRS ≥ 4/10) during the past week

Exclusion Criteria:

* psychotic depression, clinically significant bipolar disorder
* contraindication for performing brain fMRI (metal in the body etc)
Rhomboid Intercostal and Subserratus / Paravertebral Block

Postoperative pain is a significant concern following video-assisted thoracoscopic surgery (VATS). Pain after thoracic surgery not only causes a strong stress reaction and adverse emotional experience but also affects postoperative rehabilitation. Hence, different analgesia techniques, including local anesthetic infiltration, intercostal nerve block, paravertebral block, and thoracic epidural anesthesia, have been described to attenuate the intensity of acute postoperative painparavertebral block (PVB) and Rhomboid intercostal block with sub-serratus plane block (RISS) are the two types of plane blocks used for postoperative analgesia after video-assisted thoracoscopic surgery (VATS). This prospective randomized controlled trial was performed to analyze the postoperative analgesic effects of ultra- sound-guided PVB and RISS block after video-assisted thoracoscopic surgery.


Eligibility Criteria:
Inclusion Criteria:

* Planned for VATS
* American Society of Anesthesiologists (ASA) class I and II
* Patients aged between 18-80

Exclusion Criteria:

* Contraindications to local anesthetic allergy or bupivacaine
* Known or suspected coagulopathy
* Injection site infection
* History of thoracic surgery
* Severe neurological or psychiatric disorder
* Severe cardiovascular disease
* Liver failure
* Renal failure (glomerular filtration rate \<15 ml/min/1.73 m2)
* Chronic opioid use
Clinical Trial to Assess Safety of SI-6603 in Patients With Lumbar Disc Herniation

The purpose of this study is to evaluate the safety of SI-6603 in lumbar disc herniation patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with lumbar disc herniation (L4-L5 or L5-S1) as assessed by MRI and clinical symptoms corresponding to position of the impaired nerve root.
* Patients assessed as positive in the SLR test.
* Patients with sciatica in either lower leg.
* Patients with no improvement from pharmacotherapy or concomitant treatment with drug and nerve block.

Exclusion Criteria:

* Patients who have 2 or more lumbar disc herniations as assessed by MRI.
* Patients with "extrusion-type" or "sequestration-type" herniation in whom a rupture into the posterior longitudinal ligament is identified by MRI.
* Patients who have received nerve block within 3 weeks before screening.
* Patients who have undergone lumbar operation, chemonucleolysis, or percutaneous nucleotomy.
Investigation of Cognitive Function Before and After Induced Ventricular Fibrillation in Electrophysiological (EP) Study

In this study, changes in electroencephalogram (EEG) and the hemodynamic state during ventricular fibrillation or induced ventricular tachycardia are investigated.

Patients with a high risk of malignant tachyarrhythmia are routinely investigated by programmed electrophysiological study (EPS). To investigate the hemodynamic effects of ventricular arrhythmia to cerebral circulation an EEG and transcranial ultrasound are conducted simultaneously during the EPS. Before and after the EPS a neuropsychological test and an investigation of a specific blood sample (Neuron Specific Enolase, NSE) is done.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Positive agreement
* EPS for primary and secondary prophylaxis of a malignant ventricular tachyarrhythmia:

  * primary prophylaxis: Brugada syndrome, long QT syndrome, cardiomyopathy, short QT syndrome
  * secondary prophylaxis: Multicenter Automatic Defibrillator Implantation Trial (MADIT) criteria, syncope, documented ventricular tachycardia

Exclusion Criteria:

* Severe neurological deficit
* Cardiopulmonary resuscitation
IEIK13 For Neurosurgery

The objective of this clinical investigation is to determine the performance and safety profile of NU-MAX® when used as a topical hemostat for oozing bleedings encountered during intracranial procedures, in which control of bleeding by conventional hemostatic techniques is either ineffective or impractical.


Eligibility Criteria:
Inclusion Criteria:

1. Have been informed on the nature of the clinical investigation and provided written informed consent, prior to initiation of any study activities.
2. Able and willing to comply with the clinical investigation follow-up schedule.
3. Male or female human subjects aged 18 years or older at time of enrollment.
4. Requiring hemostasis during elective intracranial procedures, in which the intradural space is accessed and where the control of bleeding by conventional hemostatic techniques is either ineffective or impractical.
5. NU-MAX® is used at least once intraoperatively.

Exclusion Criteria:

1. Patients undergoing emergency craniotomy for traumatic lesions or patients undergoing surgery for primary intracranial hemorrhage.
2. Patients undergoing surgical procedures using a transsphenoidal approach.
3. Intraoperative use of a different topical chemical hemostatic agent prior to the use of NU-MAX® during the same procedure and on the same bleeding point or in the same resection cavity.
4. Patients with a coagulation disorder or medical treatment affecting coagulation or platelet function, unless corrected or stopped prior to surgery.
5. Pregnant patients or patients planning to become pregnant during the clinical investigation.
6. Patients with known allergies to any of the components of NU-MAX®.
7. Patients currently participating in, or having been recently exited from (within 30 days from enrollment in this clinical investigation), or planning to enroll in another clinical investigation that may impact participation or outcomes (at the discretion of the sponsor) of this clinical investigation.
8. Patients with a condition, disorder, or other factor that, in the investigator's opinion, would interfere with study participation.
9. Fever (body temperature \>38.5°C) prior to surgery, on the day of the procedure.
10. Patients with a Nickel allergy
The Use of Clear Aligners With Movement Enhancement Techniques

The purpose of this study is to use clear aligners to measure tooth movement and length of treatment.

Orthodontic tooth movement is the result of a force applied to the crown of a tooth and the biological remodeling of the gum and bony tissues.

Eligibility Criteria:
Inclusion Criteria:

* Require Orthodontic Treatment
* Have a permanent dentition
* No craniofacial anomaly present
* No past and present signs and symptoms of periodontal disease
* No significant medical history or medication that would adversely affect the development or structure of the teeth and jaws and any subsequent tooth movement
* No previous orthodontic or orthopaedic relapse
* No history of trauma, bruxism or parafunction
* 16- 46 years old, inclusive
* No skeletal jaw discrepancy
* Angle Class I or Class II molar and canine relationship
* Crowding of at least 4mm per arch
* No osteoporosis drugs

Exclusion Criteria:

* Subjects who do not fulfill all inclusion criteria requirements
Intratympanic Injection for Autoimmune Inner Ear Disease

The investigators plan to conduct an open-label intratympanic injection proof-of-concept trial of golimumab, a TNF-alpha inhibitor, assessing for hearing loss progression in patients with autoimmune inner ear disease (AIED). This specific aim will be achieved using a two-arm approach. First, the investigators propose to dose 3 individual subjects with a single intratympanic injection of golimumab and follow each for 30 days, closely examining them for adverse events. If there are no serious adverse events, with FDA approval, the investigators propose to dose 14 subjects, each with 4 intratympanic injections of golimumab.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of autoimmune inner ear disease (AIED) by the principal investigator
* Idiopathic, bilateral sensorineural hearing loss
* History of, or audiograms showing, rapid progression of hearing loss
* Bilateral loss of at least 30 dB in one or more frequencies (0.25 - 6 kHz)
* Hearing responsive on high-dose oral steroids and steroid-dependent, as determined by history and the principal investigator. The subject can be taking oral steroid, at the maintenance level, if enrolled in the First Arm and, if enrolled in the Second Arm, will begin taper after the first injection.
* Provided written informed consent for participation in the clinical study

Exclusion Criteria:

* Positive MRI for vestibular schwannoma
* Positive FTA (syphilis)
* Significant middle ear disease (e.g., otitis media)
* Positive blood test for Lyme disease
* Positive tuberculosis test
* Concurrent or past treatment or use of medications and/or substances known to cause ototoxicity(for example, aminoglycosides \[e.g., gentamicin\], cisplatin, loop diuretics, Yorgason et al., 2006)
* Known adverse reaction to golimumab, adalimumab, etanercept, infliximab, rituximab, ustekinumab, or other biologic immunomodulators
* Concurrent (within the past 3 months prior to enrollment) live viral intranasal vaccine (flu)
* Positive test for HIV
* Positive test for Hepatitis B and C
* Presence of a demyelinating disease, such as multiple sclerosis
* Women of childbearing potential only: Positive serum pregnancy test prior to the only/first injection
* Active infections
Care Transition Intervention for Hospitalized Patients with Advanced Cancer

This study is examining whether a care transition intervention, CONTINUUM (CONTINUity of care Under Management by video visits), consisting of a supportive care-focused video visit with an oncology nurse practitioner (NP) within three business days of hospital discharge, may improve post-discharge transitions of care for recently hospitalized patients with advanced cancer.

To address the rising incidence and burden of hospital readmissions for patients with advanced cancer, the investigators developed a population-specific care transition intervention based upon the scholarly literature and our qualitative study. The intervention, CONTINUUM (CONTINUity of care Under Management by video visits), consists of a video visit conducted by an oncology NP within three business days of hospital discharge, to: (1) reconcile medications, (2) manage symptoms, (3) review the post-hospital care plan for hospitalization-specific issues, and (4) schedule follow-up with the outpatient oncology team.

From 01/07/21 to 05/28/21, the investigators conducted a pilot trial of CONTINUUM in 48 patients with advanced cancer recently discharged from the Massachusetts General Hospital Cancer Center (NCT04640714). The investigators found that the intervention was feasible and acceptable in our population.

The investigators are now conducting a randomized controlled trial of the CONTINUUM intervention versus standard of care, to study whether CONTINUUM improves patients' confidence in managing their health condition, as measured by the Patient Activation Measure-13. The investigators will also assess the efficacy of CONTINUUM for improving patient satisfaction with clinician communication, and physical and psychological symptom burden. Lastly, the investigators will explore the effect of the intervention on hospital readmissions within 30-days.

Study procedures include random assignment to either the CONTINUUM intervention or standard oncology care following hospital discharge, questionnaires and medical record data collection.

Participants are expected to be on the study for up to 40 days after hospital discharge.

It is anticipated that about 286 people will take part in this research study.

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years
* First unplanned admission to the oncology service at Massachusetts General Hospital (MGH) since diagnosis of advanced cancer
* Known diagnosis of advanced breast, thoracic, genitourinary, or gastrointestinal cancer
* Receiving ongoing oncology care at MGH
* Verbal fluency in English
* Internet/wifi or telephone access
* Residing in Massachusetts at the time of hospital discharge

Exclusion Criteria:

* Admitted electively
* Discharged to a location other than home or expired during admission
* Discharged with hospice services
Th1/Th2/Th17/TREG and TLRs Activation/KIR for COVID 19 Prediction of Outcome

To ascertain globally the changes in the cytokines involved and TLRs/KIR activation in patients admitted to the hospital with a COVID-19 diagnosis, and the changes after initiation of the different therapies

COVID-19 is a disease with an initial viral phase followed, usually at the 7th day, of an inflammatory state (cytokine storm) leading to respiratory distress, ICU admission and risk of death. Thus, several biological agents, antagonists of the different cytokines (IL-6, IL-1) have been used for patients with severe disease. However, there are no data about the cytokine changes, at admission and after therapy, and its predictive value, a fundamental knowledge to establish the best therapeutic strategy.

The first line of immune defense is the interaction of the virus with innate immunity cell members. The toll like receptors (TLRs) family is a group of pattern recognition receptors that include many different molecules (21-23). These bindings can activate dendritic cells, monocytes, macrophages. There is an important RNA and DNA connection, activation of TLRs, the production of type I interferons, and the development of some autoimmune diseases. TLR7 and TLR8 specifically recognize simple-chain RNA of viruses and are expressed in endosomal membranes. TLR8 is expressed in regulatory cells (Treg) and its activation results in inhibition of its regulatory functions. Natural killer cells (NK) respond to alterations of class I HLA molecules present in infected cells (24-26). An increase in class I HLA expression could lead to an increase in NK activation by increasing its ability to produce IFN-gamma. Therefore, the reasons for KIR binding are often variable between individuals and between populations.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of COVID-19 (PCR confirmed)

Exclusion Criteria:

* No informed consent
* Presence of chronic therapy with immunomodulators, corticoids or antineoplastic agents.
NUTRITIONAL INTERVENTION STUDY to EVALUATE the EFFECT of a SYMBIOTIC DRINK on the MICROBIOTA and DIFFERENT NUTRITIONAL MARKERS in HEALTHY VOLUNTEERS

This study is expected to involve 60 volunteers who will be recruited by IMDEA-Alimentación and randomly assigned between a study group (which will consume the fermented drink) and a control group, which will consume a drink with similar characteristics, but without the presence of bioactive components.

At the beginning of the trial, you will have an interview (screening visit) with a dietician-nutritionist who will explain the entire procedure to you and answer any questions you may have about it. If it is confirmed that you meet the criteria to participate in the study, after your assent and informed consent have been obtained, you will be able to do so. At the first visit, you will be assigned a code by a random method (computerized) and neither you nor the researcher will know whether you are receiving the enriched product or the traditional one that will be used as a control.

Eligibility Criteria:
Inclusion Criteria:

* Men and women ≥ 18 years of age.
* Caucasian ethnicity
* Adequate level of culture and understanding of the clinical study.
* Agree to voluntarily participate in the study and give written informed consent.

Exclusion Criteria:

* Subjects with dementia, mental illness or decreased cognitive function that prevents the study from being carried out.
* Subjects with serious diseases (liver, kidney, immunosuppressed, etc.).
* BMI ≥ 30 kg/m2, pregnant or breastfeeding women.
* Presence of immunological pathologies, gallstones, gastric ulcer or coagulation problems.
* Presence of any other specific pathology that contraindicates the intake of dietary supplements, specifically inulin and probiotics (diverticulitis, etc.).
* Subjects who are undergoing antibiotic treatment or consuming probiotic supplements.
* Subjects who are undergoing pharmacological treatment for weight loss.
* Subjects who refuse to follow the guidelines for healthy eating or the consumption of the study drink in the indicated guidelines.
* Any other exclusion criteria that the principal investigator of the study considers relevant.
* Non-Caucasian ethnicity
Safety and Tolerability of AL-001 Ophthalmic Injection in Subjects with WAMD

This Phase I/IIa study is designed to evaluate the safety, tolerability, preliminary pharmacodynamics and pharmacokinetics in patients with wet age-related macular degeneration. Eligible patients, who meet the inclusion/exclusion criteria and have shown an anatomic response to an anti-VEGF (Vascular Endothelial Growth Factor) injection, will receive a single dose of AL-001 administered via suprachoroidal space injection.


Eligibility Criteria:
Inclusion Criteria:

1. Age≥ 50 and ≤ 80.
2. The study eye was diagnosed with subfoveal active choroidal neovascularization (CNV) lesions secondary to wAMD.
3. Best Corrected Visual Acuity (BCVA) of study eye during screening, Early Treatment of Diabetic Retinopathy Study (ETDRS) letters≤73 and ≥19.
4. The subject or their legal representative agrees to participate in this study and signs a written ICF.

Exclusion Criteria:

1. Non-wAMD induced CNV or macular edema in the study eye.
2. Non-wAMD induced eye conditions that may affect central vision or medical history that may seriously affect central vision in the study eye.
3. Uncontrolled glaucoma in the study eye.
4. History of vitreoretinal surgery, antiglaucoma trabeculectomy, or other anti-glaucoma filtering surgery in the study eye.
5. Refractive interstitial opacity that significantly affects visual function assessment or fundus examination in the study eye.
6. Ametropia (high myopia or high hyperopia) \> 8.0D in the study eye, or significant posterior scleral staphyloma in the study eye.
7. Malignant tumor in any eye, including but not limited to eye lymphoma or choroidal melanoma.
8. None of intraocular inflammation in the study eye.
9. Other conditions that may affect compliance or may not be suitable to participate in this trial in the opinion of investigator.
LIFEMEL Efficacy in Preventing Haematopoietic Toxicity in Patients Treated With Chemotherapy

LEO trial was designed to assess the benefit of administering LifeMel to prevent myelotoxicity in patients affected by solid neoplasm undergoing antiblastic chemotherapy treatment at low to moderate risk of febrile neutropenia. Secondary endpoints of LEO trial were assessing impact of LifeMel in preventing anaemia and thrombocytopenia.

The LEO trial was designed to assess the benefit of administering LifeMel, a honey from bees obtained using Zuf Globus Ltd technology, produced in Israel and listed by the Ministry of Health in Italy as a food supplement. This study aims to highlight a possible role of Lifemel in preventing neutropenic events, as well as reducing anaemia and thrombocytopenia following the administration of chemotherapy in patients with a histological or clinical diagnosis of solid neoplasia undergoing first-line chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* age \>=18 years old
* histological or clinical diagnosis of solid neoplasia
* indication for chemotherapy treatment with regimens at moderate risk of neutropenia fever - duration of chemotherapy treatment more than 3 months

Exclusion Criteria:

* known intolerances to honey containing compounds
* decompensated diabetes or severe glucose intolerance
* diseases or therapies significantly affecting the neutrophil count
* concurrent use of G-CSF as primary or secondary prophylaxis in the study
Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy Post Approval Registry

MADIT-CRT PAR is an FDA mandated follow-up registry for patients that participated in the MADIT-CRT IDE study examining long-term mortality.

(MADIT-CRT IDE: NCT00180271)

The registry is designed to determine the long-term mortality benefit as a result of Cardiac Resynchronization Therapy with Defibrillation (CRT-D) vs. Implantable Cardioverter Defibrillator (ICD) therapy in the MADIT-CRT study patient population. The registry will collect data on patients that previously participated at MADIT-CRT sites within the US through five years of participation from their orginal enrollment in the MADIT-CRT IDE study (MADIT-CRT IDE: NCT00180271).

Eligibility Criteria:
Inclusion Criteria:

* Active patients who were enrolled in the MADIT-CRT IDE (NCT00180271)within the United States

Exclusion Criteria:

* Patients who are unable or unwilling to comply with the protocol requirements