cyrilzakka/clinical-trials huggingface dataset:
Transplantation of Autologous Olfactory Ensheathing Cells in Complete Human Spinal Cord Injury

The purpose of this experimental therapy is an assessment of the safety and feasibility of transplantation of autologous olfactory ensheathing glia and olfactory fibroblasts obtained from the olfactory mucosa in patients with complete spinal cord injury.

The increasing number of patients (mostly young), who have sustained a spinal cord injury mainly as a result of motor vehicle accidents, falls or violence has become worldwide a serious clinical, social and economical problem. Most accepted treatment protocols for spinal cord injury focus on techniques of early neuro-protection aimed at maximal prevention of secondary spinal cord injury (administration of methylprednisolon and spinal cord surgical decompression) as well as on methods of stimulation of plasticity in the central nervous system (neurorehabilitation). While these methods have been shown to stimulate functional recovery in patients with incomplete spinal cord injury, the results of treatment of patients with severe incomplete and complete spinal cord injuries remain unsatisfactory. This is due to the lack of spontaneous regeneration of lesioned axons in the spinal cord. Results from a substantial number of animal experiments performed mainly on the model of mammalian spinal cord injury in the last 3 decades led to the establishment of numerous regeneration-promoting strategies including application of neurotrophic factors, antibodies blocking the myelin-associated proteins and transplantation of cells with neurotrophic activity. Olfactory ensheathing cells (OECs) are an unique population of macroglia found in the lamina propria of olfactory mucosa, around the olfactory nerve fascicles and in the two outer layers of the olfactory bulb. These cells have the natural ability to stimulate the regrowth of lesioned peripheral and central axons. In a Phase I non-randomized controlled prospective study we have tested the hypothesis that a combined approach for treatment of complete spinal cord injuries consisting of intraspinal transplantation of a mixture of autologous OECs and fibroblasts isolated from the olfactory mucosa, combined with intense neuro-rehabilitation is safe and feasible.

Eligibility Criteria:
Inclusion Criteria:

* spinal cord injury at subacute or chronic stage
* a single spinal cord injury between segments C5 and L5
* myelopathy confirmed by MRI, not exceeding 2 spinal cord segments
* loss of sensory and motor function below the injury, confirmed in control studies (ASIA Category A)
* age from 16 to 65 years
* patient undergoing continuous rehabilitation
* good patient motivation and cooperation
* signed informed consent

Exclusion Criteria:

* a coexisting lesion of the nervous system
* progressive post-traumatic syringomyelia
* significant spinal stenosis or instability
* persistent neuropathic pain
* muscle atrophy or joint ossifications
* severe systemic disease (neoplasm, contagious disease, diabetes etc.)
* chronic sinusitis
* tumors or polyps of nasal cavities
* persistent hyposmia or anosmia
* pregnant or breastfeeding women
Comparison of Therapy in Treatment of Patients With Helicobacter Pylori Infection: Concomitant Versus Hybrid Therapy.

The aim of the study is to compare the effectiveness of two therapeutic protocols in the treatment of Helicobacter pylori infection.

The hypothesis of our research is that the two therapeutic options (hybrid and concomitant therapy) will be equally successful in the treatment of Helicobacter pylori infection. In other words, in both therapeutic groups we expect successful treatment of Helicobacter pylori infection in or more than 90 % of patients.

In other studies, both therapeutic options have the same efficacy in treating H. pylori infection. On the other had there are no studies available in Croatia to compare the effectiveness of these therapeutic options so far, which is the main objective of our research. The secondary goals of our study will be: the existence of differences in the occurrence of possible side effects, as well as the compliance between patients in both therapeutic options. It is also our aim to compare the quality of life of patients with Helicobacter pylori infection before and after treatment, via a questionnaire that is common for this purpose.

The study is expected to include a total of 120 patients (60 patients in each therapy group), and the planned duration is 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Helicobacter pylori infection (documented by: positive antigen stool test, or positive urease rapid test obtained during upper endoscopy, or Helicobacter pylori in histological finding, or positive C-urea breath test; according to recent Maastricht V guidelines;
* written informed consent

Exclusion Criteria:

* age under 18
* previously treatment of Helicobacter pylori infection
* malignancy of stomach or other site
* history of taking proton pump inhibitors, H2 antagonist, bismuth or antibiotics (amoxicillin, metronidazole, clarithromycin) in previous month
* significant underlying disease (renal failure, psychiatric disorders)
* history of allergic reactions to any medications used in study
* refuse to participate in study
* breastfeeding and pregnancy
* quitting the study
Alpha Lipoic Acid Effect on No-Reflow Phenomenon

Prospective, randomized, open-label, controlled clinical trial to evaluate the efficacy and tolerability of Alpha Lipoic Acid administration on oxidative stress, inflammatory markers, clinical outcome and occurrence of No-Reflow in post myocardial infarction (MI) patients by assessment of aldehyde dehydrogenase-2 (ALDH2) as a marker of oxidative stress and paraoxonase-1 (PON-1) as a marker of oxidative stress and inflammation.

All (70) STEMI patients undergoing PCI presenting to the Cardiology department will be randomly assigned into one of 2 arms: 35 patients undergoing PCI who will receive standard of care , the other 35 patients undergoing PCI will receive standard of care in addition to Alpha Lipoic Acid 600 mg daily for 4 week. IV Alpha Lipoic Acid 600 mg once daily will be administered prior to PCI then orally daily for 4 week after PCI.

Baseline evaluation included demographics and history taking. After obtaining the informed consent, information including age, weight, height, smoking state, and other diseases e.g. hypertension, diabetes, hyperlipidemias, etc. will be documented for each patient. Medication history in detail, as well as the background cardiovascular treatment, will be considered.

All patients will be followed up regularly during the hospital stay and after discharge, will be assessed for the occurrence of adverse cardiac events and occurrence of adverse effects from medications

Eligibility Criteria:
Inclusion Criteria:

1. Female or male aged \>18
2. STEMI patients undergoing PCI

Exclusion Criteria:

1. Patients with a recent history of myocardial infarction (MI), a previous PCI or a previous coronary artery bypass graft
2. A late presentation (\>12 h), unsuccessful primary PCI (residual stenosis \>50% in the culprit lesion after procedure)
3. Pretreatment with thrombolytic or glycoprotein IIb/IIIa inhibitor therapy before primary PCI
4. Infectious or inflammatory disease
5. Severe liver or renal disease, (AST or ALT \>3x ULN or Total bilirubin \>2.5 x ULN), (CrCl \< 60 ml/min (based on the Cockroft-Gault equation)
6. Neoplasm, or hematological disorders
7. Pregnant or breast-feeding patients
8. Active participation in another clinical study
9. Patients taking Alpha Lipoic Acid.
10. Systolic Blood pressure \<90
Effect of the Beetroot Juice in Portuguese Swimmers

Objective: To investigate whether an acute intake of beet juice (BJ) improved the factors of total and split times (performance), stroke frequency and CMJ (biomechanics), lactate and HR (physiology) and RPE-TQR (psychophysiological) in a repeated (performance), stroke frequency and CMJ (biomechanics), lactate and HR (physiology) and RPE-TQR (psychophysiological) in a repeated maximal speed swimming effort in elite swimmers.

Methods: A total of 18 elite swimmers participated in this randomized, double-blind study. In 2 different trials, swimmers ingested a Beet-It injection (70 ml placebo (PL) or a Beet-It injection of 70 ml beet juice (BJ)) 3 hours before undergoing a 2x6x100 m intermittent maximal speed crawl performance test.


Eligibility Criteria:
Inclusion Criteria:

1. - national and international level swimmers
2. - healthy swimmers
3. - no breakfast
4. - 48 hours with restricted diet of: other sports supplements and beetroot-rich foods

Exclusion Criteria:

1. -be on medication
2. - having had breakfast
3. - have brushed your teeth
The Effect of Use of Breathing Exercise Device and Reading Aloud on Vital Signs

Purpose of the research; To determine the effects of wearable technology follow-up, breathing exercises with a breathing exercise device and reading aloud on vital signs, fatigue and respiratory function parameters in individuals with COPD. This research will be conducted using a randomized controlled trial model. "Personal Description Form", "COPD and Asthma Fatigue Scale", Visual Analog Scale and pulmonary function tests will be used in data collection.


Eligibility Criteria:
Inclusion Criteria:

* Having been diagnosed with COPD for at least 6 months or before
* Not having a respiratory system defect caused by diseases other than COPD
* Not in the GOLD-4 COPD stage
* Being able to read and write Turkish
* Have no problems communicating or speaking
* Being able to use basic information technologies
* Using a smartphone
* Having an active internet connection

Exclusion Criteria:

* Having non-COPD pulmonary problems and diagnosed cardiovascular disease
* Not volunteering to participate in the study
* Having a psychiatric disorder such as schizophrenia or dementia that disrupts the thought process
A Randomized,Open,Controlled Clinical Study to Evaluate the Efficacy of ASC09F and Ritonavir for 2019-nCoV Pneumonia

Based on oseltamivir treatment, evaluate the efficacy and safety of ASC09/ritonavir compound tablets(ASC09F) or ritonavir tablets for 2019-nCoV infection patients.


Eligibility Criteria:
Inclusion Criteria:

1. Age:18\~55 years old, unlimited gender.
2. Laboratory (RT-PCR) confirmed infection with 2019-nCoV and accompanied with clinical manifestations.
3. Patients with newly diagnosed respiratory discomfort who have been hospitalized (The proper diagnosis time is less than 7 days).
4. Women who have no planned pregnancy in the next six months,and are willing to take effective measures to prevent contraception from the first dose of study drug to 30 days after the last dose.
5. Agree not to participate in other clinical studies within 30 days from the first dose of the study drug to the last dose.
6. Patients who voluntarily sign informed consent forms.

Exclusion Criteria:

1.2019-nCoV severe Pneumonia patients.

Meet the definition of severe pneumonia(Comply with any of the followings):

1. Respiratory distress ,RR≥30 bpm;
2. In a resting state:SPO2≤93%;
3. PaO2/ FiO2≤300mmHg.

   2.2019-nCoV critical and severe Pneumonia patients.Comply with any of the followings:Respiratory failure and need mechanical ventilation;Shock;Patients combined with other organ failure need ICU monitoring and treatment.

   3.Severe liver disease(such as:the ChildPugh score≥C;AST \> 5 times the upper limit).

   4.Patients who are allergic to the ingredients of ASC09/ritonavir compound tablets.

   5.Patients with definite contraindications in ritonavir tablets.

   6.Female subjects were positive for the pregnancy test during the screening period.

   7.Researcher judges unsuitable for participation in this clinical trial(such as:during the study patients may be transferred to hospital for treatment;patients with multiple underlying diseases, etc)
Feasibility of Performing Peripheral Pulmonary Lesion Biopsy Using Robotic Bronchoscopy-Guided Cryoprobe

This research is being done to evaluate the feasibility, and biopsy quality, of using a 1.1mm disposable cryoprobe that is passed through the working channel of the Ion Robotic bronchoscope to collect biopsy tissue.


Eligibility Criteria:
Inclusion Criteria:

- Patient clinically meets indication for peripheral lung nodule biopsy and has been scheduled for robotic bronchoscopy.

Lesion Criteria:

- Pulmonary nodules of 8-50mm in largest dimension.

Exclusion Criteria:

* Patients with known bleeding diathesis; Platelet count \< 50,000.
* Current use of systemic anticoagulation or antiplatelet therapy without the ability to hold therapy for the recommended amount of time prior to an invasive procedure (aspirin monotherapy is acceptable).
* Inability or unwillingness to give informed consent.
* Pregnant or nursing females, or females of child-bearing potential who decline a pregnancy test prior to enrollment.
* Pulmonary hypertension, defined as a right ventricular systolic pressure \> 50 mmHg.
* Individuals with current or recent systematic conditions, such as, acute kidney injury, or conditions that would mandate anticoagulation, such as a recent coronary stent.
* International Normalized Ratio (INR) \< 1.5.
* Do Not Resuscitate (DNR) status; Do Not Intubate (DNI) status.
Prevention of Delirium in Inpatients Utilizing Melatonin

A double blind randomized controlled trial investigating melatonin, 5mg, compared to placebo, given to patients at least 65 years old, admitted to the hospital on a general medical floor, to prevent delirium.

This study will be a randomized double blind controlled trial, designed to evaluate the efficacy of melatonin in decreasing the incidence of delirium in elderly hospitalized adults compared to a placebo capsule. The study will be conducted on 4 general Internal Medicine inpatient floors at Yale-New Haven Hospital, St. Raphael's campus.

Within 24 hours of admission to the floor, study subjects will be approached by a member of the research team, and asked for informed consent. Patients that consent to participate will be randomized to either the treatment or the placebo arm. Each subject will be administered a capsule containing either placebo or 5 mg melatonin each evening at 9 p.m. The capsules will be prepared and administered by the Yale-New haven Hospital Investigational Drug Service. The capsules will be administered nightly until discharge or a maximum of 2 weeks, if the hospitalization is prolonged.

Subjects will be assessed twice daily by the floor nurses for evidence of delirium using the Short CAM (Confusion Assessment Method), which is a validated clinical tool for identifying delirium, and the current standard of practice tool for the diagnosis of delirium.

Eligibility Criteria:
Inclusion Criteria:

* Inpatient admission to a general internal medicine service

Exclusion Criteria:

* expected lifespan or length of stay ≤ 48 hours
* Non-English speaking
* Already taking melatonin or ramelteon at the time of randomization
* Presence of delirium at the time of randomization
* Unable to take oral medications
* Subject or proxy unable to provide informed consent within 18 hours of invitation or 24 hours of admission
* ALT or AST (Liver function tests) \> 3 times the upper limit of normal
* Taking warfarin, nifedipine or fluvoxamine
* Allergy to melatonin
* Unable to recall 3 words after distraction by naming the days of the week backwards beginning with Sunday
Compliance With Treatment For Patients With Hyperlipidemia

It is a prospective observational study.

Patients will be high risk patients (for developing cardiovascular events) that are treated with a statin. Patients will be enrolled at a normal clinic visit and provided with a small box containing info about the disease, a LDL self-test and two questionnaires. They will test themselves for LDL at home between normal clinic visits (normally 12 months interval) and note their value. In the end of the study all patients will fill out a questionnaire with questions if the tests and info have raised their awareness of the disease as well if their motivation to be compliant has increased.

We want to look at the possibility to put more responsibility for treatment and for reaching treatment goals on the patients since there's a big problem with compliance in this group of patients.

Consecutive patient sampling

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older and able to understand and sign the informed consent form.

  * Patients diagnosed with hyperlipidemia and a very high risk developing cardiovascular disease prescribed statin treatment according to clinical praxis and the recommendations set forth in the MPA national guideline for treatment of hyperlipidemia.

Exclusion Criteria:

* Patients contraindicated for statin treatment according to market authorization for these drugs should be excluded from the study.
* Patients participating in other clinical trials or non-interventional studies.
High-Field MRI Iron-Based Contrast-Enhanced Characterization of Multiple Sclerosis and Demyelinating Diseases

Feraheme (ferumoxytol) is FDA-approved for iron supplementation and is composed of iron oxide nanoparticles classified among the ultra-small superparamagnetic iron oxides (USPIO). In this project we hypothesize that Feraheme could become a sensitive and specific marker of active inflammation in multiple sclerosis. We will explore this hypothesis taking advantage of ultra high field strength (7T) MRI to further increase the effectiveness of the contrast agent Feraheme at revealing inflammatory activity.

Multiple sclerosis (MS) is a neurological disorder that affects young adults world-wide. Feraheme (ferumoxytol) is FDA-approved for iron supplementation and is composed of iron oxide nanoparticles classified among the ultra-small superparamagnetic iron oxides (USPIO). After IV injection, the particles are taken up by the monocyte-macrophage system and can also be used to track macrophage infiltration by magnetic resonance imaging (MRI) after systemic injection owing to the strong image contrast of the iron-loaded macrophages. Approximately 24 hours after their IV injection, free particles are cleared from the circulation and MR signal alterations are thought to arise from the capture of particles by circulating phagocytic cells that are attracted to inflammatory lesions.

In this project we hypothesize that Feraheme could become a sensitive and specific marker of active inflammation in multiple sclerosis. We will explore this hypothesis by taking advantage of ultra high field strength (7T) MRI to further increase the effectiveness of the contrast agent Feraheme at revealing inflammatory activity.

Eligibility Criteria:
Inclusion Criteria:

* Patients will be included if they are at least 18 years old and meet the revised diagnostic criteria for multiple sclerosis, relapsing remitting type.
* Patients will be included based on MR evidence of disease activity after Gadolinium (enhanced lesion) on a previous screening MR in the previous 3 weeks days before Feraheme administration.

Exclusion Criteria:

* Children (age \< 18)
* Those who lack decision-making capability
* Contraindication to MRI such as pacemaker, other MR-incompatible metal implants or claustrophobia
* Known allergy to dextran or drugs containing iron salts or any previous history of severe allergic reactions
* Evidence of iron overload such as hemochromatosis or other hematologic disorders that imply iron level superior to the normal level.
* Pregnancy or breast feeding.
* History of renal disease or estimated glomerular filtration rate (eGFR) using the Modification of Diet in Renal Disease (MDRD) \<40ml/min/1.73m?
Evaluation of Effectiveness and Safety of Belotero Balance® (+) Lidocaine for Volume Augmentation of the Infraorbital Hollow

* Confirm the effectiveness of Belotero Balance® (+) Lidocaine (BBL) injection for the correction of volume loss in the infraorbital hollow (IOH) area by demonstrating superiority to untreated control.
* Confirm the safety of BBL injection for the correction of volume loss in the IOH area.


Eligibility Criteria:
Inclusion Criteria:

* Is a candidate for bilateral IOH treatment.
* Has symmetrical right and left IOHs with the same MIHAS score of 2 or 3 (moderate or severe), as assessed live by the blinded evaluator.

Exclusion Criteria:

* Prior lower-eyelid surgery, including orbital or midface surgery, or a permanent implant or graft in the midfacial region that could interfere with effectiveness assessments.
* Previous treatment with fat injections or permanent and/or semi-permanent dermal fillers in the midfacial region.
* Previous lower-eyelid and/or malar-region treatments with any dermal fillers (e.g., collagen, hyaluronic acid (HA), calcium hydroxyapatite, poly L-lactic acid (PLLA)) within the past 24 months.
* Any other medical condition with the potential to interfere with the study outcome assessments or compromise subject safety.
Pharmacologic Impact on Sedation Assessments

PISA is an ancillary study to the NIH funded clinical RESTORE Trial (U01 HL086622). This study will provide data that may allow for improved dosing recommendations in this critically ill population of children.

PISA is an ancillary study to the NIH funded clinical RESTORE Trial (U01 HL086622). This project will use sophisticated modeling and simulation techniques to evaluate the impact of genetics and other variables such as degree of illness, age, weight and organ dysfunction on the pharmacokinetics and pharmacodynamics of morphine and midazolam in children who are mechanically ventilated for respiratory failure, and require sedation. This proposed work will allow the design of a pharmacologic model that can be used to individualize therapy in children requiring mechanical ventilation with the goal of optimizing sedation while minimizing the duration of mechanical ventilation. This study will provide data that may allow for improved dosing recommendations in this critically ill population of children.

Eligibility Criteria:
Inclusion Criteria:• Enrolled in RESTORE clinical trial

* Be greater than or equal to 7 kg
* Receiving morphine and/or midazolam continuous infusions
* Give Informed Consent/Assent

Exclusion Criteria:

* Intubated and mechanically ventilated for immediate post-operative care and stabilization
* Cyanotic heart disease with unrepaired or palliated right to left intracardiac shunt
* History of single ventricle at any stage of repair
* Congenital diaphragmatic hernia or paralysis
* Primary pulmonary hypertension
* Critical airway (e.g., post laryngotracheal construction) or anatomical obstruction of the lower airway (e.g., mediastinal mass)
* Ventilator dependent (including noninvasive) on Pediatric Intensive Care Unit (PICU) admission (chronic assisted ventilation)
* Neuromuscular respiratory failure
* Spinal cord injury above the lumbar region
* Pain managed by patient controlled analgesia (PCA) or epidural catheter
* Family/medical team has decided not to provide full support (patient treatment considered futile)
* Enrolled in any other sedation clinical trial concurrently or within the last 30 days
* Known allergy to any of the study medications.
Study of Milnacipran for the Treatment of Fibromyalgia

The purpose of this study was to demonstrate the efficacy and safety of milnacipran at a dosage of 100 mg/day in the treatment of the fibromyalgia syndrome or the pain associate with fibromyalgia.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of fibromyalgia defined by 1990 American College of Rheumatology (ACR) Criteria

Exclusion Criteria:

* psychiatric illness,
* depression,
* suicidal risk,
* substance abuse,
* pulmonary dysfunction,
* renal impairment,
* active cardiac disease,
* liver disease,
* autoimmune disease,
* cancer,
* inflammatory bowel disease