cyrilzakka/clinical-trials huggingface dataset:
Feasibility Study of the Microwave Ablation System for Lung Tissue Ablation

Evaluation of safety and technical feasibility of the phenoWave MW Ablation System for microwave ablation of lesions in the lung.

This study is a prospective, single-arm, single-center, study to evaluate the safety and technical feasibility of using the phenoWave MW Ablation System to deliver microwave energy for ablation of lesions in the lung.

Eligibility Criteria:
Inclusion Criteria:

* Age 45-77 years at screening.
* Confirmed NSCLC or solitary metastatic (oligometastatic) or pulmonary metastases from an extra thoracic primary tumor lung nodule through diagnostic biopsy
* Must be eligible for curative lung resection (lobectomy).
* For primary tumor, pre-ablated parenchymal tumor/lesion size ≥ 20 mm if NSCLC, or ≥ 10 mm for metastatic disease in diameter as measured from pre-operative CT image.
* Willing to participate in all aspects of study protocol for duration of study.
* Able to understand study requirements.
* Signs informed consent form.
* Boundary of tumor is at least 15 mm away from the pleura wall and/or fissure.

Exclusion Criteria:

* Any contraindication to bronchoscopy, for example:

  * Untreatable life-threatening arrhythmias.
  * Inability to adequately oxygenate the patient during the procedure.
  * Acute respiratory failure with hypercapnia (unless the patient is intubated and ventilated).
  * Recent myocardial infarction.
  * Uncorrectable coagulopathy.
* Known coagulopathy.
* Platelet dysfunction or platelet count \< 100 x 109 cells/L OR taking anticoagulant or antiplatelet agents that cannot be safely ceased in the opinion of the pulmonologist or surgeon.
* History of major bleeding with bronchoscopy.
* Suspected pulmonary hypertension.
* Moderate-to-severe pulmonary fibrosis.
* Severe emphysema (GOLD III/IV) or chronic obstructive pulmonary disease (COPD) within 3cm of tumor/lesion boundary: prior COPD assessment data is evaluated and PI consent is required.
* Bullae \>5 centimeter (cm) located in vicinity of target tumor/lesion.
* Any other severe or life-threatening comorbidity that could increase the risk of bronchoscopic MWA, for example:

  * American Society of Anesthesiologists (ASA) physical status classification \>P3
  * Stage 3 heart failure
  * Severe cachexia
  * Severe respiratory insufficiency or hypoxia
* Ongoing systemic infection.
* Contraindication to general anesthesia.
* Inability to stop anticoagulants (e.g., heparin, Warfarin) or antiplatelet agents (e.g. aspirin, clopidogrel) prior to procedure.
* Participation in any other study in last 30 days.
* Breastfeeding women or females of childbearing potential with a positive pregnancy test prior to the procedure or the intent to become pregnant during the study.
* Life expectancy of less than 6 months.
* Prior radiation therapy treatment in the target lobe.
* Implantable pacemaker or defibrillator.
Safety and Pregnancy Outcomes in Thrombocythemia Patients Exposed to XAGRID® (Anagrelide Hydrochloride) Compared to Other Treatments

This is an observational safety study being conducted in Europe comparing patients taking Xagrid to patients taking other cytoreductive treatments. The plan is to enrol at least 750 subjects taking Xagrid with up to 3000 subjects taking other cytoreductive therapies. The study will collect follow up data for 5 years for each patient enrolled that will focus on collecting data related to pre-defined events (PDEs) and Suspected Serious Adverse Reactions (SSARs).


Eligibility Criteria:
Inclusion Criteria:

* High risk ET patients
* Subjects who can give written informed consent.
* Subjects taking cytoreductive therapy

Exclusion Criteria:

* Contraindications listed by the product being used.
* Patient cannot be participating in another clinical trial.
Vestibular Intervention Via Portable Electrical Stimulator (VIPES)

The purpose of this study is to develop a vestibular interventional approach using stochastic vestibular stimulation (SVS) through a small, lightweight device, and a comfortable electrode set on the back of the head that stimulates the vestibular system and produces immediate improvements in balance, gait, and overall vestibular function for patients will balance disorder.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be able to consent to participate themselves.
* Must be able to attend in-person sessions at the Mayo Aerospace Medicine and - Vestibular Research Laboratory in Scottsdale, AZ.
* No racial/ethnic groups will be excluded.
* All participants must be fluent speakers of English.

Exclusion Criteria:

* Presence of peripheral vestibulopathy (cleared by Dix-Hallpike, vHIT as part of clinical evaluation).
* Women who are pregnant.
* Inability to complete testing (e.g., severe symptom burden, inability to stand unassisted).
Effect of Remote Ischaemic Conditioning on Clinical Outcomes in STEMI Patients Undergoing PPCI (CONDI2/ERIC-PPCI)

The purpose of this study is to determine whether remote ischemic conditioning can reduce cardiac death and hospitalization for heart failure at 12 months in patients presenting with a ST-elevation myocardial infarction and treated by percutaneous coronary intervention.

The CONDI2/ERIC-PPCI trial is a randomised controlled clinical trial investigating whether remote ischemic conditioning (RIC) can reduce cardiac death and hospitalization for heart failure at 12 months in 5400 patients presenting with a ST-elevation myocardial infarction (STEMI) and treated by percutaneous coronary intervention (PPCI).

Eligibility Criteria:
Inclusion criteria:

1. Onset of STEMI symptoms within 12 hours, lasting for more than 30 minutes
2. Patients older than 18 years
3. Suspected STEMI (ST-elevation at the J-point in two contiguous leads with the cutoff points: ≥0.2 millivolt (mV) in men or ≥0.15 mV in women in leads V2-V3 and/or ≥0.1 mV in other leads)

Exclusion criteria:

1. Previous coronary artery bypass graft surgery
2. Myocardial infarction within the previous 30 days
3. Treatment with thrombolysis within the previous 30 days
4. Left bundle branch block
5. Patients treated with therapeutic hypothermia
6. Conditions precluding use of RIC (paresis of upper limb, use of an a-v shunt)
7. Life expectancy of less than 1 year due to non-cardiac pathology
Light Therapy for Obsessive-compulsive Disorder (OCD)

The purpose of this study is to examine the effect of a light-based circadian treatment on OCD symptoms in adults with OCD and late bedtimes. This study will have important implications for understanding the role of circadian rhythms in the etiology and treatment of OCD.

Prior to the start of this study, there are screening procedures to ensure participants meet the criteria for the study. At the first consent screening appointment, participants will learn more about the study and answer questionnaires. All of the results of the screening procedures are confidential and will only be used by the study staff to determine eligibility for the study.

This study is 5 weeks long and involves 4 in-person lab visits at the Sleep and Chronobiology Lab. Participants will be randomly assigned to either an active or placebo light therapy treatment condition. Visit 1 will involve additional screening to determine eligibility, including questionnaires and interviews. If eligible, participants will then track their sleep for 2 weeks at home with a wrist-worn activity monitor and a sleep diary. Visit 2 will take place in the lab from 5:30pm until 1 hour after participants typical bedtime. The investigators will ask participants to provide saliva samples hourly to measure melatonin and complete questionnaires. The investigators will provide treatment instructions at this visit. Investigators will then ask participants to engage in the treatment at home for 3 weeks. Investigators will schedule 1 in-person visit (Visit 3) and 1 phone call to assess adherence to the treatment during these 3 weeks. Visit 4 will take place in the lab after the treatment is finished. Visit 4 will last from 5:30pm until 1.5 hours after participants typical bedtime and will involve hourly saliva samples to measure melatonin, questionnaires, and interviews.

Eligibility Criteria:
Inclusion Criteria:

* Primary OCD diagnosis (according to the Diagnostic and Statistical Manual of Mental Disorders 5)
* Bedtime 0100 or later
* Age 18-35
* English speaking

Exclusion Criteria:

* Subjects must not be currently participating in another research study that would influence their participation in our study.
* Past 6-month substance use disorder
* Lifetime psychosis or bipolar disorder
* Current sleep disorder (DSWPD and insomnia excepted)
* Significant, active suicidal ideation or behaviors in the past 6 months
* Intellectual disability
* Engaged in evidence-based psychotherapy for OCD
* History of light therapy or cognitive behavior therapy for insomnia
* Night shift work or travel outside of Mountain Standard Time in the past month
* Pregnant, trying to become pregnant, or breastfeeding
* Change in psychotropic medication in the past month
* Prescribed or over the counter sleep medication use in the past month
* Beta-block or monoamine oxidase inhibitor use in the past month
Influence of Intraoperative Fluid Balance on the Incidence of Adverse Events in Pediatric Cardiac Surgery

The intraoperative fluid balance during pediatric cardiac surgery is a very sensitive parameter given the low circulating volume and the complexity of anesthetic management but might be deleterious if inadequately managed. The hypothesis is that a highly positive intraoperative fluid balance increases the incidence of adverse events in the short and long term.

A retrospective observational study including all consecutive children admitted for cardiac surgery with cardiopulmonary bypass (CPB) from 2008 to 2018 in a tertiary children's hospital will be performed. A multivariate analysis will be carried out to study the effect of the fluid balance on the incidence of adverse events.


Eligibility Criteria:
Inclusion Criteria:

* Children aged 0-16 years and
* Cardiac surgery with cardiopulmonary bypass and
* operated between 2008 and 2018 at the Queen Fabiola University Children's Hospital (tertiary children's hospital)

Exclusion Criteria:

* ASA (American Society of Anesthesiologists) score of 5
* Jehovah's Witnesses
* incomplete hospital record
Safety of SPD465 in Treating Adults With ADHD.

The purpose of this study is to assess the safety and effectiveness of SPD465 in the treatment of ADHD. The study will also look at how SPD465 affects sleep.


Eligibility Criteria:
Inclusion Criteria:

* Subject satisfied all entry criteria for the antecedent protocol (SPD465-301 or SPD465-303) and completed a minimum of 4 of the 7 weeks of double-blind treatment without experiencing any clinically significant adverse events.
* Subject must be male or non-pregnant female who agrees to comply with using acceptable contraceptive methods.

Exclusion Criteria:

* Subject was terminated from antecedent protocol (SPD465-301 or SPD465-303) for non-compliance and/or experienced a serious adverse event or adverse event resulting in termination from the protocol.
* Comorbid psychiatric diagnosis with significant symptoms such as Axis II disorders or severe Asix I disorders.
* History of seizure, tic disorder, or a current diagnosis and/or family history of Tourette's Disorder.
* Females who are pregnant of lactating.
An Investigation of a New Laryngeal Mask Airway LMA Protector

Evaluation of LMA Protector

This new disposable silicone airway device provides access and functional separation of the respiratory and digestive tracts. The airway tube is elliptical in cross section ending at the laryngeal opening. The device contains 2 drainage channels (male and female port) proximally that continues into a common distal opening posterior to the distal airway cuff bowl. The female port allows a gastric tube to be passed into the stomach, whilst a suction tube may be attached to the male suction port offering removal of gastric fluid around the upper oesophagus sphincter.

Eligibility Criteria:
Inclusion Criteria:

* planned elective surgery with indication for LMA use

Exclusion Criteria:

* body mass index of 30 or more, known gastro-oesophageal reflux, patients with increased risk of aspiration, upper airway pathology and mouth opening of less than 2 cm
Effects of Upper Limb Motor and Robotic Training Over Neuroplasticity and Function Capacity

The purpose of this study is to evaluate and compare the effects of upper limb training with Induced Constraint Therapy (ICT) or robotic therapy. No placebo therapy is used. Motor function, neurological evaluations and quality of life are assessed for the comparison of the therapies.

The trial is being carried out in the Institute of Physical Medicine and Rehabilitation of the University of São Paulo since February 2012. The investigators are including patients with clinical diagnosis of Ischemic or hemorrhagic stroke.

The patients are being randomized in blocks of four, six and eight, in two arms: ICT: patients are undergoing 60 minutes physiotherapy and occupational therapy twice a week for ten consecutive weeks. Other therapeutic services as phonoaudiology, psychology, nutrition, physical conditioning are prescribed upon the patients' medical demands. After the 10 weeks, the patients are undergoing two whole weeks of daily ICT as to reach 90% of the time under constraint, including weekends. During this last period, no other therapeutic service is offered, but the occupational therapy under ICT. Patients are not allowed to undergo robotic therapy.

Robotic therapy: patients are undergoing robotic occupational therapy for 60 minutes, three times a week for twelve consecutive weeks. All other therapeutic services are prescribed upon the patients' medical demands. Patients are not allowed to undergo ICT.

The investigator and the raters are blind to treatment.

The evaluations are done prior to the beginning of the treatment and at the end of it. The follow up assessments are done at 3 and 12 months after the end of the treatment.

The sample size was estimated to be 62 patients in each arm, a total size of 124 patients

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of stroke;
* Patients from 6 months after stroke up to 36 months after stroke;
* Clinically stable;
* Upper limb Brunnstrom scale III or IV;
* Brunnstrom scale above V if clinician supports patients will benefit from treatment;
* Minimum wrist extension of 20°, and minimum of 10° of metacarpophalangeal active extension.
* Signed Informed Consent Form;

Exclusion Criteria:

* Mini-Mental score lower than 20 points;
* Previous multiple strokes;
* Bone diseases and articulation injuries ;
* Presence of psychological disturbances capable of diminishing adherence;
* Articulation pain within the range of motion proposed by the therapies;
* Participation in another study protocol for upper limbs therapies.
* Previous treatment with robotic assisted therapies.
Fixating the Plate of Ahmed Valve to the Sclera Using a Flanged Prolene Suture

this study evaluated new technique for suturing the Ahmed valve device used to treat resistant types of glaucoma

This technique of fixating Ahmed glaucoma valve using flanged prolene suture is an safe, fast, and reproducible technique combines the benefits of fixing the plate with excellent stability with no complications of free plate techniques at the same time, decreasing both the risks of old valve plate fixation techniques and the concerns of the relative technical difficulty

Eligibility Criteria:
Inclusion Criteria:

* Patients with IOP more than 21 mmHg , evidence of progressive optic nerve damage, retinal nerve fiber layer defects or typical glaucomatous visual field defects despite maximal tolerable medical or laser treatment are scheduled for surgery.

Exclusion Criteria:

* The exclusion criteria were as follows: patients below 18 years old, those with active uveitis and angle closure glaucoma patients.
BCI and Evaluation of Visual and Task Performance in Subjects With Eye Diseases

The purpose of this research study is to better understand the impact of visual impairment caused by different eye diseases on the ability to perform daily activities and compare it to that in patients without eye diseases.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be between the ages of 18 and 90 years old;
* Both males and females will be included.
* Be able and willing to provide signed informed consent and follow study instructions

Exclusion Criteria:

* Subjects will be excluded if they present with any systemic conditions that in the opinion of the Principal Investigator may prevent them from completing the tests.
Ketoprofen Topical Patch, 20% in the Treatment of Pain Associated With Osteoarthritis Flare of the Knee

The purpose of this study is to evaluate the effect of a ketoprofen topical patch on the pain associated with Osteoarthritis Flare of the Knee.

This randomized, double-blind placebo-controlled parallel group study will be conducted with patients who have experienced a flare of osteoarthritis of the knee. At screening, patients whose pain is currently controlled by an analgesic will agree, after giving Informed Consent, to discontinue that analgesic. Eligible patients will be randomized (1:1 ratio) to receive double-blind treatment with either the ketoprofen topical patch or a matching placebo patch to be applied once daily for 28 days. Patients will return to the clinic on Days 7, 14, 21 and 28. At Day 28, patients may choose to open a 2 month open-label period.

Patients will rate their pain using the Knee Injury and Osteoarthritis Outcome Score (KOOS) which contains the WOMAC pain subscale. Patients will also complete an electronic diary in which pain intensity, pain relief, and quality of sleep ratings will be captured. In addition, rescue medication consumption data will be collected. Ibuprofen will be provided as prn rescue medication.

Eligibility Criteria:
Inclusion Criteria:

* Males or females 18 years of age or older
* Diagnosis of osteoarthritis of the knee (unilateral or bilateral)
* Meet pain entry criteria
* Willing to discontinue use of all analgesic medications (including over-the-counter \[OTC\] analgesics) except those provided as the study treatment and rescue medication specifically for study purposes.

Exclusion Criteria:

* Positive urine pregnancy test, pregnant or lactating.
* Have fibromyalgia, inflammatory arthritis, gout, pseudo-gout or Paget's disease
* Have any other type of clinically significant joint disease or have had joint replacement surgery at the index knee
* Have received either a corticosteroid injection in the 4 weeks preceding the screening visit or hyaluronic acid within 6 months of the screening visit
* Have a history or physical examination finding that is incompatible with safe participation in the study or study product use
* Are taking medications or other substances contraindicated due to the nature of the study medication or the potential for drug interactions.
* Have significant renal or hepatic impairment
* Are taking a sleep medication at a dose that has not been stable for at least 3 months
Fresh Versus Old Red Blood Cells for Transfusion

Packed red blood cell units destined for transfusion can be stored for up to 42 days prior to transfusion based on Food and Drug Administration (FDA) guidelines. Recent studies suggest that certain patients transfused with blood stored for longer duration have poorer outcomes than patients transfused fresher blood. The investigators' hypothesis is that the delivery of an immediate and substantial load of hemoglobin-associated iron from a stored unit of blood leads to changes that explain the differences in outcome between patients transfused old versus fresh blood. The investigators propose to test this hypothesis in humans by transfusing an individual's own blood, both fresh and after storage, and comparing levels of various outcome measures.

Participants in this study will be asked to participate in a standard blood donation. The blood will be processed per standards at the investigators regional blood center (New York Blood Center) and then split into two equal units and shipped to Columbia University Medical Center for storage and transfusion. One unit will be transfused back into the same individual fresh (i.e. between 3-7 days after donation). The other unit will be transfused 42 days after donation. Blood samples will be drawn before, during, and after transfusion to measure levels of various analytes.

Eligibility Criteria:
Inclusion Criteria:

* healthy
* male body weight \>130 lbs, female body weight \> 155 lbs
* male height \>5'1", female height \>5'5"
* hemoglobin \>13.3 g/dL

Exclusion Criteria:

* ineligible for donation based on the New York Blood Center autologous blood donor questionnaire
* systolic blood pressure \>180 or \<90 mm Hg
* diastolic blood pressure \>100 or \<50 mm Hg
* heart rate \<50 or \>100
* temperature \>99.5 F prior to donation
* temperature \>100.4 F or subjective feeling of illness prior to transfusion
* positive results on standard blood donor infectious disease testing
* pregnancy.
A Study to Test Efficacy, Safety, and Pharmacokinetics of Certolizumab Pegol in Children and Adolescents With Moderately to Severely Active Crohn's Disease

The purpose of the study is to assess efficacy, safety and tolerability of 2 dose regimens of certolizumab pegol


Eligibility Criteria:
Inclusion Criteria:

* Participant must be 6 to 17 years, inclusive, at the time of signing informed consent/assent
* Participant has been diagnosed with active Crohn's disease (CD) as confirmed by endoscopic examination with/without histological confirmation ≤12 weeks before the Screening Visit
* Participant has moderately to severely active disease despite current treatment
* Participant has an inadequate response or intolerance to conventional therapy
* Participants are certolizumab pegol (CZP) and adalimumab (ADA) naïve

Exclusion Criteria:

* Participant has had an extensive colonic resection, subtotal or total colectomy, diagnosis of short bowel syndrome or a history of \>3 small bowel resections
* Participant has had a primary failure (ie, lack of response within the first 12 weeks of treatment) to any anti-Tumor necrosis factor-α agent for treatment of Crohn's disease